E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
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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 |
To assess whether two doses of dabigatran etexilate (110 mg b.i.d., 150 mg b.i.d.) as compared to UFH, both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective PCI. |
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E.2.2 | Secondary objectives of the trial |
- To assess the coagulation profile of two different doses of dabigatran etexilate in addition to a standard dual antiplatelet regimen in the setting of elective PCI. - To investigate the safety of dabigatran etexilate plus dual antiplatelet therapy, particularly with respect to bleeding complications.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible for the study if they are: 1. between 18 and 85 years of age, both included 2. due to undergo an elective (non urgent) PCI on one or multiple lesions in the native coronary vessel(s) via a femoral approach 3. if they provide informed consent.
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E.4 | Principal exclusion criteria |
Patients are excluded from this study if: 1. Not a candidate for PCI. Lesion specific conditions: - Left main disease - Chronic Total Occlusions - Bifurcation lesions, or hemodynamic sidebranch - Three vessel disease requiring treatment of more than 2 lesions (no staging is allowed) - PCI for restenosis. 2. New York Heart Association class III or IV congestive heart failure. 3. Hemodynamic instability. 4. Severe hypertension not adequately controlled by antihypertensive therapy at the screening visit (Blood Pressure > 180/110mmHg). 5. Significant mitral or aortic valves disease. 6. Increased bleeding risk: - Ischemic stroke within the last year or history of any previous hemorrhagic stroke, or intracranial aneurysm - Recent (< 1 month) trauma or major surgery (including bypass surgery) in the last 3 months - Symptomatic or endoscopically documented ulcer disease in the previous 30 days - Active or recent (< 3 months) major, minor TIMI definition-bleeding - Impaired hemostasis: Thrombocytopenia ( platelet count <100*109) or active bleeding disorder - Anticoagulant (heparin, coumarin) use; international normalized ratio >1.5 - Use of oral non steroidal inflammatory drugs (NSAID) within 12 hrs prior to PCI - Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophillia; acquired bleeding disorders; and unexplained clinically significant bleeding disorders) 7. Thrombolytic therapy within 24 hours preceding randomization 8. Severe renal impairment (e.g. known creatinine clearance < 30 mL/min (GFR -assessed by the Modification of Diet in Renal Disease (MDRD) study equation) or clinical markers of severe renal impairment) [R02-2429] [R02-2529] 9. Known liver disease (e.g. known high concentrations of liver enzymes (more than twice the ULN)) 10. Pre-menopausal (last menstruation < 1 year prior to screening) sexually active women who: are pregnant or nursing or are not surgically sterile or are of child bearing potential and not practicing an acceptable method of birth control, (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, double barrier or vasectomised partner) 11. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (Visit 1) 12. Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study 13. Use of quinidine 14. Known allergy, hypersensitivity or contraindication to clopidogrel, aspirin. 15. Inability to give informed consent or high likelihood of being unavailable for follow-up 16. Inability or unwillingness to perform 7-14 day follow up 17. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).
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E.5 End points |
E.5.1 | Primary end point(s) |
Anticoagulant effect will be determined based on the number of patients who need rescue anticoagulant and/or have clinical signs of catheter related thrombosis during the PCI procedure (until removal of the guiding catheter and the patient has left the catheterization suite). |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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 | 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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End of trial is the last subject last visit |
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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 | 1 |
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 | 1 |