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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01776424




Registration number
NCT01776424
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013

Titles & IDs
Public title
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Scientific title
A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
Secondary ID [1] 0 0
2012-004180-43
Secondary ID [2] 0 0
15786
Universal Trial Number (UTN)
Trial acronym
COMPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention & Control 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Aspirin
Treatment: Drugs - Aspirin placebo
Treatment: Drugs - Rivaroxaban placebo
Treatment: Drugs - Pantoprazole
Treatment: Drugs - Pantoprazole placebo

Experimental: Rivaroxaban 2.5mg + Aspirin 100mg - Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

Experimental: Rivaroxaban 5mg + Aspirin Placebo - Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

Active comparator: Rivaroxaban Placebo + Aspirin 100mg - Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 2.5 mg, twice daily, oral

Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Tablet, 5 mg, twice daily, oral

Treatment: Drugs: Aspirin
Tablet, 100 mg, once daily, oral

Treatment: Drugs: Aspirin placebo
Aspirin matching placebo, once daily, oral

Treatment: Drugs: Rivaroxaban placebo
Rivaroxaban matching placebo, twice daily, oral

Treatment: Drugs: Pantoprazole
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole

Treatment: Drugs: Pantoprazole placebo
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
Timepoint [1] 0 0
For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Primary outcome [2] 0 0
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
Timepoint [2] 0 0
For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary outcome [1] 0 0
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
Timepoint [1] 0 0
For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary outcome [2] 0 0
The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death
Timepoint [2] 0 0
For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary outcome [3] 0 0
All-cause Mortality
Timepoint [3] 0 0
For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

Eligibility
Key inclusion criteria
- Meet criteria for CAD and/or PAD

Subjects with CAD must also meet at least one of the following criteria:

* Age =65, or
* Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
* Estimated glomerular filtration rate (eGFR)<15 mL/min
* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy

Study design
Purpose of the study
Prevention
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
28/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
27395
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Bruce
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- New Lambton Heights
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- Taree
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- Birtinya
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- Brisbane
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- Redcliffe
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- Woolloongabba
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- Adelaide
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- Hobart
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- Launceston
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- Geelong
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- Melbourne
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- Prahran
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- Murdoch
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- Nedlands
Recruitment postcode(s) [1] 0 0
2617 - Bruce
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2250 - Gosford
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2305 - New Lambton Heights
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2430 - Taree
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4575 - Birtinya
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4029 - Brisbane
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4064 - Brisbane
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4020 - Redcliffe
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4102 - Woolloongabba
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5042 - Adelaide
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7000 - Hobart
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7250 - Launceston
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3220 - Geelong
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3052 - Melbourne
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3181 - Melbourne
Recruitment postcode(s) [16] 0 0
3181 - Prahran
Recruitment postcode(s) [17] 0 0
6150 - Murdoch
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Country [189] 0 0
Japan
State/province [189] 0 0
Yamaguchi
Country [190] 0 0
Japan
State/province [190] 0 0
Gifu
Country [191] 0 0
Japan
State/province [191] 0 0
Kumamoto
Country [192] 0 0
Japan
State/province [192] 0 0
Kyoto
Country [193] 0 0
Korea, Republic of
State/province [193] 0 0
Gang''weondo
Country [194] 0 0
Korea, Republic of
State/province [194] 0 0
Gyeonggido
Country [195] 0 0
Korea, Republic of
State/province [195] 0 0
Jejudo
Country [196] 0 0
Korea, Republic of
State/province [196] 0 0
Seoul Teugbyeolsi
Country [197] 0 0
Korea, Republic of
State/province [197] 0 0
Busan
Country [198] 0 0
Korea, Republic of
State/province [198] 0 0
Daejeon
Country [199] 0 0
Korea, Republic of
State/province [199] 0 0
Seoul
Country [200] 0 0
Malaysia
State/province [200] 0 0
Batu Caves, Selangor
Country [201] 0 0
Malaysia
State/province [201] 0 0
Kedah
Country [202] 0 0
Malaysia
State/province [202] 0 0
Kuala Lumpur
Country [203] 0 0
Malaysia
State/province [203] 0 0
Selangor
Country [204] 0 0
Malaysia
State/province [204] 0 0
Sungai Buloh Selangor
Country [205] 0 0
Netherlands
State/province [205] 0 0
Amsterdam
Country [206] 0 0
Netherlands
State/province [206] 0 0
Apeldoorn
Country [207] 0 0
Netherlands
State/province [207] 0 0
Arnhem
Country [208] 0 0
Netherlands
State/province [208] 0 0
Breda
Country [209] 0 0
Netherlands
State/province [209] 0 0
Delft
Country [210] 0 0
Netherlands
State/province [210] 0 0
Den Bosch
Country [211] 0 0
Netherlands
State/province [211] 0 0
Deventer
Country [212] 0 0
Netherlands
State/province [212] 0 0
Doetinchem
Country [213] 0 0
Netherlands
State/province [213] 0 0
Drachten
Country [214] 0 0
Netherlands
State/province [214] 0 0
EDE
Country [215] 0 0
Netherlands
State/province [215] 0 0
Gorinchem
Country [216] 0 0
Netherlands
State/province [216] 0 0
Gouda
Country [217] 0 0
Netherlands
State/province [217] 0 0
Groningen
Country [218] 0 0
Netherlands
State/province [218] 0 0
Heerlen
Country [219] 0 0
Netherlands
State/province [219] 0 0
Helmond
Country [220] 0 0
Netherlands
State/province [220] 0 0
Hoogeveen
Country [221] 0 0
Netherlands
State/province [221] 0 0
Hoorn
Country [222] 0 0
Netherlands
State/province [222] 0 0
Leeuwarden
Country [223] 0 0
Netherlands
State/province [223] 0 0
Meppel
Country [224] 0 0
Netherlands
State/province [224] 0 0
Nijmegen
Country [225] 0 0
Netherlands
State/province [225] 0 0
Roermond
Country [226] 0 0
Netherlands
State/province [226] 0 0
Roosendaal
Country [227] 0 0
Netherlands
State/province [227] 0 0
Rotterdam
Country [228] 0 0
Netherlands
State/province [228] 0 0
Sneek
Country [229] 0 0
Netherlands
State/province [229] 0 0
Tiel
Country [230] 0 0
Netherlands
State/province [230] 0 0
Zwolle
Country [231] 0 0
Philippines
State/province [231] 0 0
Batangas
Country [232] 0 0
Philippines
State/province [232] 0 0
Cebu City
Country [233] 0 0
Philippines
State/province [233] 0 0
Dagupan City
Country [234] 0 0
Philippines
State/province [234] 0 0
Dasmarinas
Country [235] 0 0
Philippines
State/province [235] 0 0
Iloilo City
Country [236] 0 0
Philippines
State/province [236] 0 0
Laoag City
Country [237] 0 0
Philippines
State/province [237] 0 0
Manila
Country [238] 0 0
Philippines
State/province [238] 0 0
Metro Manila
Country [239] 0 0
Philippines
State/province [239] 0 0
Muntinlupa City
Country [240] 0 0
Philippines
State/province [240] 0 0
Palawan
Country [241] 0 0
Philippines
State/province [241] 0 0
Pasig city
Country [242] 0 0
Philippines
State/province [242] 0 0
Quezon City
Country [243] 0 0
Philippines
State/province [243] 0 0
Tacloban City
Country [244] 0 0
Poland
State/province [244] 0 0
Gdansk
Country [245] 0 0
Poland
State/province [245] 0 0
Kielce
Country [246] 0 0
Poland
State/province [246] 0 0
Krakow
Country [247] 0 0
Poland
State/province [247] 0 0
Lodz
Country [248] 0 0
Poland
State/province [248] 0 0
Tarnow
Country [249] 0 0
Poland
State/province [249] 0 0
Wroclaw
Country [250] 0 0
Romania
State/province [250] 0 0
Timis
Country [251] 0 0
Romania
State/province [251] 0 0
Brasov
Country [252] 0 0
Romania
State/province [252] 0 0
Bucharest
Country [253] 0 0
Romania
State/province [253] 0 0
Bucuresti
Country [254] 0 0
Romania
State/province [254] 0 0
Cluj Napoca
Country [255] 0 0
Romania
State/province [255] 0 0
Iasi
Country [256] 0 0
Romania
State/province [256] 0 0
Targu Mures
Country [257] 0 0
Romania
State/province [257] 0 0
Timisoara
Country [258] 0 0
Russian Federation
State/province [258] 0 0
Barnaul
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Kemerovo
Country [260] 0 0
Russian Federation
State/province [260] 0 0
Moscow
Country [261] 0 0
Russian Federation
State/province [261] 0 0
Novosibirsk
Country [262] 0 0
Russian Federation
State/province [262] 0 0
Tomsk
Country [263] 0 0
Russian Federation
State/province [263] 0 0
Zhukovskiy
Country [264] 0 0
Slovakia
State/province [264] 0 0
Bratislava
Country [265] 0 0
Slovakia
State/province [265] 0 0
Kosice
Country [266] 0 0
Slovakia
State/province [266] 0 0
Nitra
Country [267] 0 0
Slovakia
State/province [267] 0 0
Presov
Country [268] 0 0
Slovakia
State/province [268] 0 0
Vrable
Country [269] 0 0
South Africa
State/province [269] 0 0
Eastern Cape
Country [270] 0 0
South Africa
State/province [270] 0 0
Freestate
Country [271] 0 0
South Africa
State/province [271] 0 0
Gauteng
Country [272] 0 0
South Africa
State/province [272] 0 0
Western Cape
Country [273] 0 0
South Africa
State/province [273] 0 0
Somerset West
Country [274] 0 0
Sweden
State/province [274] 0 0
Göteborg
Country [275] 0 0
Sweden
State/province [275] 0 0
Helsingborg
Country [276] 0 0
Sweden
State/province [276] 0 0
Kristianstad
Country [277] 0 0
Sweden
State/province [277] 0 0
Skellefteå
Country [278] 0 0
Sweden
State/province [278] 0 0
Stockholm
Country [279] 0 0
Sweden
State/province [279] 0 0
Vällingby
Country [280] 0 0
Sweden
State/province [280] 0 0
Örebro
Country [281] 0 0
Sweden
State/province [281] 0 0
Östersund
Country [282] 0 0
Switzerland
State/province [282] 0 0
Ticino
Country [283] 0 0
Ukraine
State/province [283] 0 0
Dnipropetrovsk
Country [284] 0 0
Ukraine
State/province [284] 0 0
Kharkiv
Country [285] 0 0
Ukraine
State/province [285] 0 0
Kiev
Country [286] 0 0
Ukraine
State/province [286] 0 0
Lviv
Country [287] 0 0
Ukraine
State/province [287] 0 0
Simferopol
Country [288] 0 0
Ukraine
State/province [288] 0 0
Vinnitsa
Country [289] 0 0
Ukraine
State/province [289] 0 0
Zaporozhye
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Antrim
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Derry
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Essex
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Hertfordshire
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Lancashire
Country [295] 0 0
United Kingdom
State/province [295] 0 0
London
Country [296] 0 0
United Kingdom
State/province [296] 0 0
North Ireland
Country [297] 0 0
United Kingdom
State/province [297] 0 0
North Yorkshire
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Northamptonshire
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Stockton-on-Tees
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Warwickshire
Country [301] 0 0
United Kingdom
State/province [301] 0 0
West Midlands
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Worcestershire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Janssen Research & Development, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, ... [More Details]
Journal Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz... [More Details]
Journal Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dy... [More Details]
Journal Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, H... [More Details]
Journal Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lani... [More Details]
Journal Braunwald E. An Important Step for Thrombocardiolo... [More Details]
Journal Fauchier L, Bisson A, Angoulvant D. Rivaroxaban in... [More Details]
Journal Berger JS. Antithrombotic therapy in peripheral ar... [More Details]
Journal Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, B... [More Details]
Journal Verheugt FWA. Return of Oral Anticoagulation in Ch... [More Details]
Journal Fox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J... [More Details]
Journal Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casa... [More Details]
Journal Kruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with... [More Details]
Journal Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effective... [More Details]
Journal Bhagirath VC, Eikelboom JW, Anand SS. Low-dose riv... [More Details]
Journal Kruger PC, Anand SS, de Vries TAC, Eikelboom JW. P... [More Details]
Journal Boden WE, Bhatt DL. Will COMPASS Point to a New Di... [More Details]
Journal Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J,... [More Details]
Journal Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakov... [More Details]
Journal Coppens M, Weitz JI, Eikelboom JWA. Synergy of Dua... [More Details]
Journal Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dy... [More Details]
Journal Fox KAA, Eikelboom JW, Shestakovska O, Connolly SJ... [More Details]
Journal Cairns JA, Eikelboom JW, Shestakovska O, Yusuf S, ... [More Details]
Journal Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dy... [More Details]
Journal Kruger PC, Guzik TJ, Eikelboom JW. How can the res... [More Details]
Journal Branch KR, Probstfield JL, Eikelboom JW, Bosch J, ... [More Details]
Journal Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, ... [More Details]
Journal Anand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C... [More Details]
Journal Fox KAA, Metra M, Morais J, Atar D. The myth of 's... [More Details]
Journal de Vries TI, Eikelboom JW, Bosch J, Westerink J, D... [More Details]
Journal Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O... [More Details]
Journal Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sh... [More Details]
Journal Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska ... [More Details]
Journal Wurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelb... [More Details]
Journal Vanassche T, Verhamme P, Anand SS, Shestakovska O,... [More Details]
Journal Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Me... [More Details]
Journal Welsh RC, Peterson ED, De Caterina R, Bode C, Gers... [More Details]
Journal Schiele F, Puymirat E, Ferrieres J, Simon T, Fox K... [More Details]
Journal Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch... [More Details]
Journal Liang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosc... [More Details]
Journal Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anan... [More Details]
Journal Steffel J, Eikelboom JW, Anand SS, Shestakovska O,... [More Details]
Journal Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW... [More Details]
Journal Kaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abo... [More Details]
Journal Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-... [More Details]
Journal Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD... [More Details]
Journal Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V... [More Details]
Journal Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, No... [More Details]
Journal Vanassche T, Verhamme P, Anand SS, Shestakovska O,... [More Details]
Journal Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly... [More Details]
Journal Anand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz... [More Details]
Journal Kaplovitch E, Anand SS. The evolving treatment of ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT01776424