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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070015 / PAS003 |
| Date Original Protocol Accepted |
07/02/2008
|
| Date Current Protocol Accepted |
07/02/2008
|
| Study Name |
Dual Antiplatelet Therapy
|
| Device Name |
XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to evaluate the effectiveness and safety 12 versus 30 months of dual antiplatelet therapy on the composite of all death, myocardial infarction and stroke free survival, as well as definite or probable ST free survival, in patients treated with drug eluting stents. The patients will be randomized to either their dual anti-platelet therapy or placebo and followed from 12 months to 30 months post index procedure.
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| Study Population |
The Xience V Everolimus Eluting Coronary Stent System was approved on July 2, 2008. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.Study population will consist of event free patients at 12 months
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| Sample Size |
Study Phase I (From index procedure to 1 year post stent implantation):8,000 patients, Study Phase II (From 1 year up to 5 years) : All patients enrolled and completed Study Phase I will be evaluated at 1-year to determine their eligibility of participating in one of the three different study cohorts in Study Phase II:1) XIENCE V USA LTF Cohort: The first 1,500 on-label patients and the remaining patients from the initial 5,000 patients who do not participate in the HCRI-DAPT cohort will be included in this cohort. 2) HCRI-DAPT Cohort: Patients who are event free in the first year and are compliant with DAPT will be identified for HCRI. 3) AV-DAPT Cohort: Up to 1,524 patients from the additional 3,000 patients who are event free in the first year and are compliant with DAPT will be included in this cohort. The approximately 440 sequentially enrolled patients from 3,841 to 5,060 that are not included in the HCRI-DAPT study will also be followed to five years post index procedure. Therefore, a total of 4,280 patients (3,840 + 440) will be followed to five years post index procedure by Abbott Vascular. The remaining 780 patients will be followed by HCRI for the HCRI-DAPT study, 275 sites
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| Key Study Endpoints |
Annual rates of ST cardiac death and myocardial infarction will be determined.
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| Follow-up Visits and Length of Follow-up |
Annually to five years. Clinical follow-up will occur at 15, 24, 30 and 33 months.
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