Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000582358
Ethics application status
Approved
Date submitted
4/11/2008
Date registered
19/11/2008
Date last updated
9/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions
Scientific title
A Prospective, Randomised, Multicentre Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element) for the Treatment of up to two De Novo Coronary Artery Lesions
Universal Trial Number (UTN)
Trial acronym
PLATINUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic lesions in the coronary artery 3918 0
Condition category
Condition code
Cardiovascular 4110 4110 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. Up to two stents will be permanently implanted in the patient via use of a catheter inserted into the vasculature. The drug dosage depends on the size of the stent and varies from 57 micrograms (2.25x12mm stent) to 242 micrograms (4.0x38mm stent) and this drug is gradually eluted into the bloodstream following implantation of the stent. Stent size is selected by the investigator based on vessel diameter and length. Typically stent diameter is selected to be slightly larger than the vessel diameter (ie a 3.0mm stent would be used to treat a 2.8mm vessel). Typically stent length is selected so that the stent is 2-4mm longer than the lesion length (ie a 28mm stent would be used to treat a 22mm lesion)
Intervention code [1] 3637 0
Treatment: Devices
Comparator / control treatment
The PROMUS Everolimus-Eluting Coronary Stent System will be used as a control device. This device contains the same drug as the PROMUS Element device but a different stent and is already approved on the Australian market. This device will be implanted in exactly the same way as the test device.
Control group
Active

Outcomes
Primary outcome [1] 5002 0
12-month target lesion failure (TLF) rate, defined as any ischaemia-driven revascularisation of the target lesion (TLR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel
Timepoint [1] 5002 0
12 month after intervention
Secondary outcome [1] 8445 0
Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:

* The patient has a positive functional study corresponding to the area served by the target lesion
* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TLR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia.

Any events must be reported to the sponsor within 24 hours. Source data regarding the event will be collected and sent to the Clinical Events Committee (CEC) for adjudication.
Timepoint [1] 8445 0
30 days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years & 5 years
Secondary outcome [2] 8446 0
Target vessel revascularization (TVR) is defined as a TLR or a TVR remote. Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:
* The patient has a positive functional study corresponding to the area served by the target lesion
* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TLR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia



Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is 50% by QCA and any of the following are present:

* The patient has a positive functional study corresponding to the area served by the target lesion

* The patient has ischemic ECG changes at rest in a distribution consistent with the target vessel
* The patient has ischemic symptoms referable to the target lesion
A TVR will be considered as ischemia-driven if the lesion diameter stenosis is 70% by QCA even in the absence of clinical or functional ischemia.

Any events must be reported to the sponsor within 24 hours. Source data regarding the event will be collected and sent to the CEC for adjudication.
Timepoint [2] 8446 0
30 days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years & 5 years

Eligibility
Key inclusion criteria
1. Patient is eligible for percutaneous coronary intervention (PCI)
2. Patient has documented stable angina pectoris, or documented silent ischaemia, or unstable angina pectoris
3. Patient is acceptable candidate for Coronary Artery Bypass Graft (CABG)
4. Patient has left ventricular ejection fraction of >30%
5. Target lesion must be de novo and located within native coromary artery with diameter >2.50mm and <4.25mm
6. Target lesion must be <24mm in length
7. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >50% and <100%
Minimum age
18 Years
Maximum age
150 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical symptoms or Electrocardiogram (ECG) changes consistent with Myocardial Infarction (MI)
2. Patient has known diagnosis of recent MI (within 30 days prior to index procedure) and has elevated enzymes at time of index procedure
3. Target vessel or side branch treated with any type of PCI within 12 months prior to index procedure
4. Patient is receiving chronic anticoagulation therapy for indications other than acute coronary syndrome

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)
Approximately 1,532 patients will be enrolled. Patients will be considered enrolled in the trial at the time of randomization. Allocation is concealed via central randomisation using an Interactive Voice Response System (IVRS)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An Interactive Voice Response System (IVRS) will be used to assign subjects to treatment groups (i.e. PROMUS or PROMUS Element stent). Randomization will be stratified by the presence or absence of diabetes mellitus treated with medication(s), by the intent to treat 1 versus 2 target lesions, and by study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1532
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1260 0
3168
Recruitment postcode(s) [2] 1261 0
5000
Recruitment postcode(s) [3] 1262 0
4032
Recruitment postcode(s) [4] 1263 0
2050
Recruitment postcode(s) [5] 1264 0
3065
Recruitment postcode(s) [6] 1265 0
2065
Recruitment postcode(s) [7] 1266 0
1871
Recruitment postcode(s) [8] 1267 0
6000
Recruitment postcode(s) [9] 1268 0
6959
Recruitment postcode(s) [10] 1269 0
6009
Recruitment outside Australia
Country [1] 1326 0
United States of America
State/province [1] 1326 0
Country [2] 1327 0
Argentina
State/province [2] 1327 0
Country [3] 1328 0
Malaysia
State/province [3] 1328 0
Country [4] 1329 0
Singapore
State/province [4] 1329 0
Country [5] 1330 0
Japan
State/province [5] 1330 0
Country [6] 1331 0
Austria
State/province [6] 1331 0
Country [7] 1332 0
Belgium
State/province [7] 1332 0
Country [8] 1333 0
Denmark
State/province [8] 1333 0
Country [9] 1334 0
France
State/province [9] 1334 0
Country [10] 1335 0
Germany
State/province [10] 1335 0
Country [11] 1336 0
Latvia
State/province [11] 1336 0
Country [12] 1337 0
United Kingdom
State/province [12] 1337 0
Country [13] 1338 0
Finland
State/province [13] 1338 0
Country [14] 1339 0
Netherlands
State/province [14] 1339 0
Country [15] 1340 0
Spain
State/province [15] 1340 0
Country [16] 1341 0
Switzerland
State/province [16] 1341 0
Country [17] 1342 0
Poland
State/province [17] 1342 0
Country [18] 1343 0
Italy
State/province [18] 1343 0
Country [19] 1344 0
Portugal
State/province [19] 1344 0
Country [20] 1345 0
New Zealand
State/province [20] 1345 0

Funding & Sponsors
Funding source category [1] 4102 0
Commercial sector/Industry
Name [1] 4102 0
Boston Scientific Corporation
Country [1] 4102 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
100 Boston Scientific Way
Marlborough
MA 01752
Country
United States of America
Secondary sponsor category [1] 3693 0
None
Name [1] 3693 0
Address [1] 3693 0
Country [1] 3693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6176 0
Ethics committee address [1] 6176 0
Ethics committee country [1] 6176 0
Date submitted for ethics approval [1] 6176 0
24/11/2008
Approval date [1] 6176 0
Ethics approval number [1] 6176 0

Summary
Brief summary
The PROMUS Element clinical trial – PLATINUM, is a prospective, multi-centre trial to evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System. Treatment will be in participants with up to 2 de novo (new or untreated) atherosclerotic coronary artery lesions. A separate coronary artery (de novo) narrowing is able to be treated with a commercial treatment (eg: stent such as PROMUS, balloon angioplasty, excluding brachytherapy) during the initial procedure. Up to 160 sites enrolling up to 1,532 patients. Follow up at hospital clinics 30 days, 6 and 12 months.
Participants enrolled who did not receive the PROMUS Element or the PROMUS stent will complete follow up at this point. The Primary Endpoint is Target Lesion Failure at 12 months defined as ischaemia-driven Target Lesion Revascularisation (repeat treatment of narrowing), Myocardial Infarction (heart attack) related to the target vessel, or Cardiac Death (participant death) related to the target vessel.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29089 0
Address 29089 0
Country 29089 0
Phone 29089 0
Fax 29089 0
Email 29089 0
Contact person for public queries
Name 12246 0
Mary Kennell
Address 12246 0
Boston Scientific
Level 5, 247 Coward Street
Mascot
NSW 2020
Country 12246 0
Australia
Phone 12246 0
+612 8063 8144
Fax 12246 0
Email 12246 0
Mary.Kennell@bsci.com
Contact person for scientific queries
Name 3174 0
Ian T Meredith
Address 3174 0
MonashHEART, Southern health
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168
Country 3174 0
Australia
Phone 3174 0
+613 9594 2726
Fax 3174 0
Email 3174 0
ian.meredith@med.monash.edu

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

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