E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with atrial fibrillation and in indication for oral anticoagulation, who are currently receiving additionally clopidogrel for another medical condition, such as acute coronary syndrome and/or coronary/carotid/peripheral 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 | LLT |
E.1.2 | Classification code | 10068617 |
E.1.2 | Term | Coronary heart disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 | 10003658 |
E.1.2 | Term | Atrial fibrillation |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 10047065 - Vascular 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 primary hypothesis to be tested is whether dabigatran is superior to phenprocoumon in the reduction of clopidogrel mediated ADP induced platelet aggregation.
The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on 14 day after initiation of therapy. |
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E.2.2 | Secondary objectives of the trial |
1. Platelet function tests ( ADPtest HS (MEA) 6.4µmol/l ADP in the presence of 9.4 nmol/l prostaglandin E1, TRAP-6 (32µmol/l), Collagen (3.2µg/ml collagen (COLtest))
2. Coagulation parameters (aPTT, INR, Thrombin coagulation Time)
3. Dabigatran Plasmalevels
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score≥ 1).
2. INR ≤ 1.6 at study entry
3. Current clopidogrel treatment
4. 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. Cardiogenic shock
3. Current therapy with dabigatran, Ketoconazole, Amiodarone, Chinidin, Rifampicin, St. John's wort
(Johanniskraut), Verapamil or Carbamazepine
4. INR > 1.6
5. Patients with a recent thrombembolic event (severe disabling stroke in the last 6 months or any stroke in the last 14 days) and/or high thrombembolic risk (mechanical valve, pulmonary embolism, deep vein thrombosis or LV thrombus) requiring bridging therapy with either unfractionated heparin or LMWH
6. Contraindication for oral anticoagulation
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. Severe renal insufficiency (Creatinine Clearance <30ml/min)
9. Moderate or severe hepatic impairment (Child-Pugh class B or C) or with elevated hepatic transaminases >2 times the upper limit of normal
10. Planned major surgery within the next 2 weeks with the need to discontinue antithrombotic therapy
11. Known allergy or intolerance to the study medications and their ingredients: dabigatran (GelborangeS), phenprocoumon
12. Pregnancy (present, suspected or planned) or positive pregnancy test
(In women with childbearing potential a pregnancy test is mandatory)
13. Relevant hematologic deviations: hemoglobin < 10 g/dL; platelet count < 100 x 109 cells/L or platelet count > 600 x 109 cells/L
14. Previous enrollment in this trial
15. 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) |
The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on 14 day after initiation of therapy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |