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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00809965




Registration number
NCT00809965
Ethics application status
Date submitted
16/12/2008
Date registered
17/12/2008
Date last updated
17/09/2014

Titles & IDs
Public title
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
Secondary ID [1] 0 0
RIVAROXACS3001
Secondary ID [2] 0 0
CR014710
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Myocardial Infarction 0 0
Myocardial Ischemia 0 0
Unstable Angina 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban 2.5 mg
Treatment: Drugs - Rivaroxaban 5 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of care

Experimental: Rivaroxaban 2.5 mg bid - One 2.5 mg rivaroxaban tablet twice daily for up to 6 months

Experimental: Rivaroxaban 5 mg bid - One 5 mg rivaroxaban tablet twice daily for up to 6 months

Placebo Comparator: Placebo - One placebo tablet twice daily for up to 6 months


Treatment: Drugs: Rivaroxaban 2.5 mg
One tablet twice daily

Treatment: Drugs: Rivaroxaban 5 mg
One tablet twice daily

Treatment: Drugs: Placebo
One placebo tablet twice daily

Treatment: Drugs: Standard of care
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
Timepoint [1] 0 0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary outcome [1] 0 0
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
Timepoint [1] 0 0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary outcome [2] 0 0
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
Timepoint [2] 0 0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary outcome [3] 0 0
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
Timepoint [3] 0 0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary outcome [4] 0 0
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
Timepoint [4] 0 0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

Eligibility
Key inclusion criteria
- Patients must be currently receiving aspirin therapy alone or in combination with a
thienopyridine per national or local dosing recommendation

- Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted
at least 10 minutes at rest and occurred 48 hours or less before going to the hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any condition that, in the opinion of the investigator, contraindicates anticoagulant
therapy or would have an unacceptable risk of bleeding

- Need for continued anticoagulant therapy

- Significant renal impairment or known significant liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
15526
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- Chermside N/A
Recruitment hospital [3] 0 0
- Coffs Harbour South
Recruitment hospital [4] 0 0
- Douglas
Recruitment hospital [5] 0 0
- Epping
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- Fremantle
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- Heidelberg
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- Herston
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- Launceston
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- Milton
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- Newcastle
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- Parkville
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- Perth
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- Southport
Recruitment hospital [15] 0 0
- Woolloongabba N/A
Recruitment postcode(s) [1] 0 0
- Bedford Park
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- Chermside N/A
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- Milton
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- Parkville
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- Perth
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- Southport
Recruitment postcode(s) [15] 0 0
- Woolloongabba N/A
Recruitment outside Australia
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United States of America
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Lucknow Gpo
Country [216] 0 0
India
State/province [216] 0 0
Ludhiana
Country [217] 0 0
India
State/province [217] 0 0
Madurai
Country [218] 0 0
India
State/province [218] 0 0
Mangalore
Country [219] 0 0
India
State/province [219] 0 0
Mumbai
Country [220] 0 0
India
State/province [220] 0 0
Mysore
Country [221] 0 0
India
State/province [221] 0 0
Nagpur
Country [222] 0 0
India
State/province [222] 0 0
Nasik
Country [223] 0 0
India
State/province [223] 0 0
New Delhi
Country [224] 0 0
India
State/province [224] 0 0
Pune
Country [225] 0 0
India
State/province [225] 0 0
Surat
Country [226] 0 0
India
State/province [226] 0 0
Trissur
Country [227] 0 0
India
State/province [227] 0 0
Trivandrum
Country [228] 0 0
India
State/province [228] 0 0
Vadodara
Country [229] 0 0
India
State/province [229] 0 0
Vijayawada
Country [230] 0 0
Israel
State/province [230] 0 0
Afula
Country [231] 0 0
Israel
State/province [231] 0 0
Hadera
Country [232] 0 0
Israel
State/province [232] 0 0
Haifa
Country [233] 0 0
Israel
State/province [233] 0 0
Jerusalem
Country [234] 0 0
Israel
State/province [234] 0 0
Nahariya
Country [235] 0 0
Israel
State/province [235] 0 0
Petah Tikva
Country [236] 0 0
Israel
State/province [236] 0 0
Rehovot
Country [237] 0 0
Israel
State/province [237] 0 0
Safed
Country [238] 0 0
Israel
State/province [238] 0 0
Tel Aviv
Country [239] 0 0
Israel
State/province [239] 0 0
Tiberias
Country [240] 0 0
Japan
State/province [240] 0 0
Anan
Country [241] 0 0
Japan
State/province [241] 0 0
Fukui
Country [242] 0 0
Japan
State/province [242] 0 0
Fukuoka-Shi,
Country [243] 0 0
Japan
State/province [243] 0 0
Fukuyama-City,
Country [244] 0 0
Japan
State/province [244] 0 0
Gifu-City
Country [245] 0 0
Japan
State/province [245] 0 0
Higashiosaka-City
Country [246] 0 0
Japan
State/province [246] 0 0
Kagoshima-City
Country [247] 0 0
Japan
State/province [247] 0 0
Kanazawa-City
Country [248] 0 0
Japan
State/province [248] 0 0
Kasuga
Country [249] 0 0
Japan
State/province [249] 0 0
Kawachinagano-City
Country [250] 0 0
Japan
State/province [250] 0 0
Kawasaki-City
Country [251] 0 0
Japan
State/province [251] 0 0
Kisarazu-City
Country [252] 0 0
Japan
State/province [252] 0 0
Kobe-City
Country [253] 0 0
Japan
State/province [253] 0 0
Kobe-Shi
Country [254] 0 0
Japan
State/province [254] 0 0
Kumamoto-City
Country [255] 0 0
Japan
State/province [255] 0 0
Kumamoto
Country [256] 0 0
Japan
State/province [256] 0 0
Kuwana-City
Country [257] 0 0
Japan
State/province [257] 0 0
Maebashi-City Gunma
Country [258] 0 0
Japan
State/province [258] 0 0
Matsudo-City
Country [259] 0 0
Japan
State/province [259] 0 0
Matsumoto
Country [260] 0 0
Japan
State/province [260] 0 0
Matsuyama-City Ehime
Country [261] 0 0
Japan
State/province [261] 0 0
Miyazaki-Gun
Country [262] 0 0
Japan
State/province [262] 0 0
Nagano-City
Country [263] 0 0
Japan
State/province [263] 0 0
Nagasaki
Country [264] 0 0
Japan
State/province [264] 0 0
Nagoya-City
Country [265] 0 0
Japan
State/province [265] 0 0
Nagoya
Country [266] 0 0
Japan
State/province [266] 0 0
Namegata-City
Country [267] 0 0
Japan
State/province [267] 0 0
Nankoku-City
Country [268] 0 0
Japan
State/province [268] 0 0
Nishinomiya
Country [269] 0 0
Japan
State/province [269] 0 0
Okayama-City
Country [270] 0 0
Japan
State/province [270] 0 0
Osaka-City
Country [271] 0 0
Japan
State/province [271] 0 0
Osaka
Country [272] 0 0
Japan
State/province [272] 0 0
Sakaide-City
Country [273] 0 0
Japan
State/province [273] 0 0
Sakura-Shi
Country [274] 0 0
Japan
State/province [274] 0 0
Suwa-City
Country [275] 0 0
Japan
State/province [275] 0 0
Tokushima-City
Country [276] 0 0
Japan
State/province [276] 0 0
Tokushima
Country [277] 0 0
Japan
State/province [277] 0 0
Tokyo,
Country [278] 0 0
Japan
State/province [278] 0 0
Tokyo
Country [279] 0 0
Japan
State/province [279] 0 0
Toyama-City
Country [280] 0 0
Japan
State/province [280] 0 0
Urasoe-City
Country [281] 0 0
Japan
State/province [281] 0 0
Yamaguchi
Country [282] 0 0
Japan
State/province [282] 0 0
Yokohama N/A
Country [283] 0 0
Japan
State/province [283] 0 0
Yokohama-City
Country [284] 0 0
Japan
State/province [284] 0 0
Yokohama-Shi
Country [285] 0 0
Japan
State/province [285] 0 0
Yokohama
Country [286] 0 0
Japan
State/province [286] 0 0
Yonago-Shi
Country [287] 0 0
Korea, Republic of
State/province [287] 0 0
Daejeon
Country [288] 0 0
Korea, Republic of
State/province [288] 0 0
Gwangju
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Seognam-Si, Kyungki-Do
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Seoul
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Suwon
Country [292] 0 0
Latvia
State/province [292] 0 0
Daugavpils
Country [293] 0 0
Latvia
State/province [293] 0 0
Liepaja
Country [294] 0 0
Latvia
State/province [294] 0 0
Riga
Country [295] 0 0
Lithuania
State/province [295] 0 0
Kaunas
Country [296] 0 0
Lithuania
State/province [296] 0 0
Klaipeda
Country [297] 0 0
Lithuania
State/province [297] 0 0
Siauliai
Country [298] 0 0
Lithuania
State/province [298] 0 0
Vilnius Lt
Country [299] 0 0
Lithuania
State/province [299] 0 0
Vilnius
Country [300] 0 0
Malaysia
State/province [300] 0 0
Johor Bahru
Country [301] 0 0
Malaysia
State/province [301] 0 0
Kelantan
Country [302] 0 0
Malaysia
State/province [302] 0 0
Kota Samarahan
Country [303] 0 0
Malaysia
State/province [303] 0 0
Kuala Lumpur
Country [304] 0 0
Malaysia
State/province [304] 0 0
Selayang N/A
Country [305] 0 0
Mexico
State/province [305] 0 0
Aguascalientes
Country [306] 0 0
Mexico
State/province [306] 0 0
Cd. Juarez
Country [307] 0 0
Mexico
State/province [307] 0 0
Ciudad De Mexico
Country [308] 0 0
Mexico
State/province [308] 0 0
Culiacan
Country [309] 0 0
Mexico
State/province [309] 0 0
Guadalajara
Country [310] 0 0
Mexico
State/province [310] 0 0
Leon
Country [311] 0 0
Mexico
State/province [311] 0 0
Mexico
Country [312] 0 0
Mexico
State/province [312] 0 0
Monterrey
Country [313] 0 0
Mexico
State/province [313] 0 0
Queretaro
Country [314] 0 0
Mexico
State/province [314] 0 0
San Luis Potosi
Country [315] 0 0
Mexico
State/province [315] 0 0
Sinaloa
Country [316] 0 0
Mexico
State/province [316] 0 0
Veracruz
Country [317] 0 0
Mexico
State/province [317] 0 0
Zapopan
Country [318] 0 0
Morocco
State/province [318] 0 0
Marrakech
Country [319] 0 0
Morocco
State/province [319] 0 0
Meknès
Country [320] 0 0
Morocco
State/province [320] 0 0
Rabat
Country [321] 0 0
Netherlands
State/province [321] 0 0
Amsterdam
Country [322] 0 0
Netherlands
State/province [322] 0 0
Arnhem
Country [323] 0 0
Netherlands
State/province [323] 0 0
Delft
Country [324] 0 0
Netherlands
State/province [324] 0 0
Den Haag
Country [325] 0 0
Netherlands
State/province [325] 0 0
Eindhoven
Country [326] 0 0
Netherlands
State/province [326] 0 0
Gorinchem
Country [327] 0 0
Netherlands
State/province [327] 0 0
Gouda
Country [328] 0 0
Netherlands
State/province [328] 0 0
Haarlem
Country [329] 0 0
Netherlands
State/province [329] 0 0
Harderwijk
Country [330] 0 0
Netherlands
State/province [330] 0 0
Hengelo Ov
Country [331] 0 0
Netherlands
State/province [331] 0 0
Nieuwegein
Country [332] 0 0
Netherlands
State/province [332] 0 0
Nijmegen
Country [333] 0 0
Netherlands
State/province [333] 0 0
Sittard
Country [334] 0 0
Netherlands
State/province [334] 0 0
Vlaardingen
Country [335] 0 0
New Zealand
State/province [335] 0 0
Auckland
Country [336] 0 0
New Zealand
State/province [336] 0 0
Dunedin
Country [337] 0 0
New Zealand
State/province [337] 0 0
Hamilton
Country [338] 0 0
New Zealand
State/province [338] 0 0
Lower Hutt
Country [339] 0 0
New Zealand
State/province [339] 0 0
Nelson
Country [340] 0 0
New Zealand
State/province [340] 0 0
New Plymouth
Country [341] 0 0
Philippines
State/province [341] 0 0
Iloilo City
Country [342] 0 0
Philippines
State/province [342] 0 0
Marikina City
Country [343] 0 0
Philippines
State/province [343] 0 0
Quezon City
Country [344] 0 0
Poland
State/province [344] 0 0
Bedzin
Country [345] 0 0
Poland
State/province [345] 0 0
Bialystok
Country [346] 0 0
Poland
State/province [346] 0 0
Bielsko-Biala
Country [347] 0 0
Poland
State/province [347] 0 0
Bydgoszcz
Country [348] 0 0
Poland
State/province [348] 0 0
Bytom
Country [349] 0 0
Poland
State/province [349] 0 0
Dabrowa Górnicza
Country [350] 0 0
Poland
State/province [350] 0 0
Gdynia
Country [351] 0 0
Poland
State/province [351] 0 0
Gorlice
Country [352] 0 0
Poland
State/province [352] 0 0
Katowice N/A
Country [353] 0 0
Poland
State/province [353] 0 0
Katowice-Ochojec
Country [354] 0 0
Poland
State/province [354] 0 0
Katowice
Country [355] 0 0
Poland
State/province [355] 0 0
Koszalin
Country [356] 0 0
Poland
State/province [356] 0 0
Krakow N/A
Country [357] 0 0
Poland
State/province [357] 0 0
Krakow
Country [358] 0 0
Poland
State/province [358] 0 0
Kutno
Country [359] 0 0
Poland
State/province [359] 0 0
Lodz
Country [360] 0 0
Poland
State/province [360] 0 0
Nowy Targ
Country [361] 0 0
Poland
State/province [361] 0 0
Opole
Country [362] 0 0
Poland
State/province [362] 0 0
Plock
Country [363] 0 0
Poland
State/province [363] 0 0
Poznan N/A
Country [364] 0 0
Poland
State/province [364] 0 0
Poznan
Country [365] 0 0
Poland
State/province [365] 0 0
Ruda Slaska
Country [366] 0 0
Poland
State/province [366] 0 0
Starogard Gdanski Nap
Country [367] 0 0
Poland
State/province [367] 0 0
Szczecin N/A
Country [368] 0 0
Poland
State/province [368] 0 0
Szczecin
Country [369] 0 0
Poland
State/province [369] 0 0
Torun
Country [370] 0 0
Poland
State/province [370] 0 0
Warszawa N/A
Country [371] 0 0
Poland
State/province [371] 0 0
Warszawa
Country [372] 0 0
Poland
State/province [372] 0 0
Wloclawek
Country [373] 0 0
Poland
State/province [373] 0 0
Wroclaw
Country [374] 0 0
Poland
State/province [374] 0 0
Zamosc
Country [375] 0 0
Portugal
State/province [375] 0 0
Aveiro
Country [376] 0 0
Portugal
State/province [376] 0 0
Braga
Country [377] 0 0
Portugal
State/province [377] 0 0
Coimbra
Country [378] 0 0
Portugal
State/province [378] 0 0
Faro
Country [379] 0 0
Portugal
State/province [379] 0 0
Leiria
Country [380] 0 0
Portugal
State/province [380] 0 0
Lisboa
Country [381] 0 0
Portugal
State/province [381] 0 0
Penafiel
Country [382] 0 0
Portugal
State/province [382] 0 0
Porto
Country [383] 0 0
Portugal
State/province [383] 0 0
Vila Nova De Gaia
Country [384] 0 0
Romania
State/province [384] 0 0
Bucuresti
Country [385] 0 0
Romania
State/province [385] 0 0
Craiova
Country [386] 0 0
Romania
State/province [386] 0 0
Focsani
Country [387] 0 0
Romania
State/province [387] 0 0
Oradea
Country [388] 0 0
Romania
State/province [388] 0 0
Pitesti
Country [389] 0 0
Romania
State/province [389] 0 0
Tg Mures
Country [390] 0 0
Romania
State/province [390] 0 0
Timisoara
Country [391] 0 0
Russian Federation
State/province [391] 0 0
Arkhangelsk
Country [392] 0 0
Russian Federation
State/province [392] 0 0
Barnaul
Country [393] 0 0
Russian Federation
State/province [393] 0 0
Chelyabinsk
Country [394] 0 0
Russian Federation
State/province [394] 0 0
Ekaterinburg
Country [395] 0 0
Russian Federation
State/province [395] 0 0
Ivanovo
Country [396] 0 0
Russian Federation
State/province [396] 0 0
Kaliningrad
Country [397] 0 0
Russian Federation
State/province [397] 0 0
Kemerovo
Country [398] 0 0
Russian Federation
State/province [398] 0 0
Kirov
Country [399] 0 0
Russian Federation
State/province [399] 0 0
Krasnodar
Country [400] 0 0
Russian Federation
State/province [400] 0 0
Krasnoyarsk
Country [401] 0 0
Russian Federation
State/province [401] 0 0
Kursk
Country [402] 0 0
Russian Federation
State/province [402] 0 0
Lyubertsy
Country [403] 0 0
Russian Federation
State/province [403] 0 0
Moscow N/A
Country [404] 0 0
Russian Federation
State/province [404] 0 0
Moscow
Country [405] 0 0
Russian Federation
State/province [405] 0 0
Nizhny Novgorod
Country [406] 0 0
Russian Federation
State/province [406] 0 0
Novosibirsk
Country [407] 0 0
Russian Federation
State/province [407] 0 0
Omsk
Country [408] 0 0
Russian Federation
State/province [408] 0 0
Orenburg
Country [409] 0 0
Russian Federation
State/province [409] 0 0
Penza
Country [410] 0 0
Russian Federation
State/province [410] 0 0
Perm
Country [411] 0 0
Russian Federation
State/province [411] 0 0
Pskov
Country [412] 0 0
Russian Federation
State/province [412] 0 0
Pushkin, Saint-Petersburg
Country [413] 0 0
Russian Federation
State/province [413] 0 0
Ryazan
Country [414] 0 0
Russian Federation
State/province [414] 0 0
Saint-Petersbrug
Country [415] 0 0
Russian Federation
State/province [415] 0 0
Saint-Petersburg
Country [416] 0 0
Russian Federation
State/province [416] 0 0
Sestroretsk, Saint-Petersburg
Country [417] 0 0
Russian Federation
State/province [417] 0 0
St Petersburg N/A
Country [418] 0 0
Russian Federation
State/province [418] 0 0
St Petersburg
Country [419] 0 0
Russian Federation
State/province [419] 0 0
St. Petersburg
Country [420] 0 0
Russian Federation
State/province [420] 0 0
Syktyvkar
Country [421] 0 0
Russian Federation
State/province [421] 0 0
Tomsk
Country [422] 0 0
Russian Federation
State/province [422] 0 0
Tula
Country [423] 0 0
Russian Federation
State/province [423] 0 0
Tumen Region
Country [424] 0 0
Russian Federation
State/province [424] 0 0
Vladimir
Country [425] 0 0
Russian Federation
State/province [425] 0 0
Voronezh
Country [426] 0 0
Russian Federation
State/province [426] 0 0
Yaroslavl Nap
Country [427] 0 0
Serbia
State/province [427] 0 0
Belgrade
Country [428] 0 0
Serbia
State/province [428] 0 0
Beograd
Country [429] 0 0
Serbia
State/province [429] 0 0
Kragujevac
Country [430] 0 0
Serbia
State/province [430] 0 0
Niska Banja
Country [431] 0 0
Serbia
State/province [431] 0 0
Nis
Country [432] 0 0
Slovakia
State/province [432] 0 0
Bratislava
Country [433] 0 0
Slovakia
State/province [433] 0 0
Nové Zámky
Country [434] 0 0
Slovakia
State/province [434] 0 0
Zilina
Country [435] 0 0
Spain
State/province [435] 0 0
Alicante N/A
Country [436] 0 0
Spain
State/province [436] 0 0
Aviles Asturias
Country [437] 0 0
Spain
State/province [437] 0 0
Barcelona
Country [438] 0 0
Spain
State/province [438] 0 0
Burgos
Country [439] 0 0
Spain
State/province [439] 0 0
Elche
Country [440] 0 0
Spain
State/province [440] 0 0
Figueres
Country [441] 0 0
Spain
State/province [441] 0 0
Guadalajara
Country [442] 0 0
Spain
State/province [442] 0 0
Huelva N/A
Country [443] 0 0
Spain
State/province [443] 0 0
Madrid
Country [444] 0 0
Spain
State/province [444] 0 0
Malaga
Country [445] 0 0
Spain
State/province [445] 0 0
Málaga
Country [446] 0 0
Spain
State/province [446] 0 0
Salamanca
Country [447] 0 0
Spain
State/province [447] 0 0
Santander
Country [448] 0 0
Spain
State/province [448] 0 0
Sevilla
Country [449] 0 0
Spain
State/province [449] 0 0
Tarragona
Country [450] 0 0
Spain
State/province [450] 0 0
Valencia
Country [451] 0 0
Spain
State/province [451] 0 0
Vigo
Country [452] 0 0
Sweden
State/province [452] 0 0
Danderyd
Country [453] 0 0
Sweden
State/province [453] 0 0
Göteborg
Country [454] 0 0
Sweden
State/province [454] 0 0
Jönköping
Country [455] 0 0
Sweden
State/province [455] 0 0
Linköping
Country [456] 0 0
Sweden
State/province [456] 0 0
Lund
Country [457] 0 0
Sweden
State/province [457] 0 0
Malmö
Country [458] 0 0
Sweden
State/province [458] 0 0
Umeå
Country [459] 0 0
Sweden
State/province [459] 0 0
Örebro
Country [460] 0 0
Sweden
State/province [460] 0 0
Östersund
Country [461] 0 0
Thailand
State/province [461] 0 0
Bangkok
Country [462] 0 0
Thailand
State/province [462] 0 0
Chiang Mai
Country [463] 0 0
Thailand
State/province [463] 0 0
Pathumthani
Country [464] 0 0
Thailand
State/province [464] 0 0
Phathumwan
Country [465] 0 0
Tunisia
State/province [465] 0 0
Sfax
Country [466] 0 0
Tunisia
State/province [466] 0 0
Sousse
Country [467] 0 0
Tunisia
State/province [467] 0 0
Tunis
Country [468] 0 0
Turkey
State/province [468] 0 0
Ankara
Country [469] 0 0
Turkey
State/province [469] 0 0
Aydin
Country [470] 0 0
Turkey
State/province [470] 0 0
Bursa
Country [471] 0 0
Turkey
State/province [471] 0 0
Erzurum
Country [472] 0 0
Turkey
State/province [472] 0 0
Istanbul
Country [473] 0 0
Turkey
State/province [473] 0 0
Izmir
Country [474] 0 0
Turkey
State/province [474] 0 0
Kayseri
Country [475] 0 0
Turkey
State/province [475] 0 0
Samsun
Country [476] 0 0
Turkey
State/province [476] 0 0
Sivas
Country [477] 0 0
Ukraine
State/province [477] 0 0
Cherkassy
Country [478] 0 0
Ukraine
State/province [478] 0 0
Dnepropetrovsk
Country [479] 0 0
Ukraine
State/province [479] 0 0
Donetsk
Country [480] 0 0
Ukraine
State/province [480] 0 0
Ivano-Frankivsk
Country [481] 0 0
Ukraine
State/province [481] 0 0
Kharkov
Country [482] 0 0
Ukraine
State/province [482] 0 0
Khemelnitskiy
Country [483] 0 0
Ukraine
State/province [483] 0 0
Kiev
Country [484] 0 0
Ukraine
State/province [484] 0 0
Lugansk
Country [485] 0 0
Ukraine
State/province [485] 0 0
Lutsk
Country [486] 0 0
Ukraine
State/province [486] 0 0
Lviv
Country [487] 0 0
Ukraine
State/province [487] 0 0
Nikolaev
Country [488] 0 0
Ukraine
State/province [488] 0 0
Poltava
Country [489] 0 0
Ukraine
State/province [489] 0 0
Sumy
Country [490] 0 0
Ukraine
State/province [490] 0 0
Ternopol
Country [491] 0 0
Ukraine
State/province [491] 0 0
Uzhgorod
Country [492] 0 0
Ukraine
State/province [492] 0 0
Vinnitsa
Country [493] 0 0
Ukraine
State/province [493] 0 0
Zaporozhye
Country [494] 0 0
Ukraine
State/province [494] 0 0
Zhytomir
Country [495] 0 0
United Kingdom
State/province [495] 0 0
Birmingham
Country [496] 0 0
United Kingdom
State/province [496] 0 0
Blackpool
Country [497] 0 0
United Kingdom
State/province [497] 0 0
Bristol
Country [498] 0 0
United Kingdom
State/province [498] 0 0
Chertsey
Country [499] 0 0
United Kingdom
State/province [499] 0 0
Chesterfield
Country [500] 0 0
United Kingdom
State/province [500] 0 0
East Sussex
Country [501] 0 0
United Kingdom
State/province [501] 0 0
Exeter
Country [502] 0 0
United Kingdom
State/province [502] 0 0
Hampshire
Country [503] 0 0
United Kingdom
State/province [503] 0 0
Harrow
Country [504] 0 0
United Kingdom
State/province [504] 0 0
Hull
Country [505] 0 0
United Kingdom
State/province [505] 0 0
Leicester
Country [506] 0 0
United Kingdom
State/province [506] 0 0
Lincoln
Country [507] 0 0
United Kingdom
State/province [507] 0 0
Manchester
Country [508] 0 0
United Kingdom
State/province [508] 0 0
Middlesbrough
Country [509] 0 0
United Kingdom
State/province [509] 0 0
Portadown
Country [510] 0 0
United Kingdom
State/province [510] 0 0
Stockport
Country [511] 0 0
United Kingdom
State/province [511] 0 0
Warwick
Country [512] 0 0
United Kingdom
State/province [512] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether rivaroxaban in addition to standard care
reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke
in patients with a recent acute coronary syndrome compared with placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00809965
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00809965