E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with established coronary artery disease on chronic clopidogrel therapy at 6 months after coronary drug eluting stent implantation. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The hypothesis to be tested is that a clopidogrel therapy duration of 6 months after coronary drug-eluting stent implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy.
The primary end point of the study is a composite of death, myocardial infarction, stent thrombosis (definite or probable according to Academic Research Consortium [ARC] criteria), stroke or TIMI major bleeding. |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoint contains the individual components of the primary endpoint.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
2. Informed, written consent by the patient
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E.4 | Principal exclusion criteria |
1. Age ≤18 years
2. Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
3. Previous stent thrombosis
4. DES in left main coronary artery
5. STEMI and NSTEMI during the last 6 months
6. Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
7. Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
8. Active bleeding; bleeding diathesis; history intracranial bleeding
9. Oral anticoagulation therapy with coumadin derivatives
10. Known allergy or intolerance to the study medications: aspirin and clopidogrel
11. Pregnancy (present, suspected or planned) or positive pregnancy test
(In women with childbearing potential a negative pregnancy test is mandatory)
12. Patient’s inability to fully comply with the study protocol
13. Prior enrollment in the same clinical trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The hypothesis to be tested is that a clopidogrel therapy duration of 6 months after DES implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy. The primary end point of the study is a composite of death, myocardial infarction, stent thrombosis (definite or probable according to Academic Research Consortium [ARC] criteria), stroke or TIMI major bleeding. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Detailed information is given in the study protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |