E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with coronary artery disease and ongoing treatment with an oral anticoagulant agent (warfarin), who have indication for treatment with a drug-eluting stent and therefore have indication for aspirin and clopidogrel treatment. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
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 |
|
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 |
To evaluate the duration of clopidogrel treatment after coronary drug-eluting stent implantation in patients treated with an oral anticoagulant agent (warfarin) and aspirin. The primary hypothesis is that 6 weeks clopidogrel treatment is superior to 6 months clopidogrel treatment. |
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E.2.2 | Secondary objectives of the trial |
Ischemic complications (composite of cardiac death, myocardial infarction, stentthrombosis or ischemic stroke)
Bleeding complications (TIMI major bleeding)
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with an indication for oral anticoagulation and a DES implantation.
2. Informed, written consent by the patient or her/his legally-authorized
representative for participation in the study.
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|
E.4 | Principal exclusion criteria |
1. Age ≤18 years
2. Previous stent thrombosis
3. DES in left main
4. Cardiogenic shock
5. Malignancies or other comorbid conditions with life expectancy less than
one year or that may result in protocol non-compliance.
6. Planned major surgery within the next 9 months with the need to
discontinue antiplatelet therapy
7. Active bleeding; bleeding diathesis; recent trauma or major surgery in the
last month; history of intracranial bleeding or structural abnormalities;
suspected aortic dissection;
8. Known allergy or intolerance to the study medications: ASA, clopidogrel,
phenprocoumon, warfarin and heparin.
9. Pregnancy (present, suspected or planned) or positive pregnancy test.
(In women with childbearing potential a pregnany test is mandatory.)
10. Relevant hematologic deviations:
hemoglobin < 10 g/dL platelet count < 100 x 109 cells/L or platelet count
> 600 x 109 cells/L.
11. Previous enrollment in this trial.
12. Patient’s inability to fully comply with the study protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine whether there are differences in the cumulative incidence of death, myocardial infarction, definite stent thrombosis, stroke or TIMI major bleeding during nine months follow-up in patients receiving a 6 week or a 6 month duration of clopidogrel therapy together with ASA and oral anticoagulation. |
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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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
When 600 patients have been enrolled and the visit of the last patient included in the trial has been followed for 9 months. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |