E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with coronary syndrome undergoing CABG in cardiopulmonary bypass receiving postoperative treatment with aspirin alone |
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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 | LLT |
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 evaluate the effect of additon of clopidogrel 75 mg daily for 6 months to lifelong aspirin in patients after CBAG on graft patency 3 months postoperatively |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of additon of clopidogrel 75 mg daily for 6 months to lifelong aspirin in patients after CBAG on development of ischemic events within 6 months postoperatively |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Patients undergoing elective CABG surgery in cardiopulmonary bypass · Age > 18 years and able to give informed consent · Stable vital signs within normal reference range (pulse within 20% of preoperatively, blood pressure within 10% of preoperatively, respiration frequency <18 breaths/min, normal consciousness) on the 1st postoperative day at time of inclusion
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E.4 | Principal exclusion criteria |
1. Age < 18 years
2. Cardiovascular · ST-segment elevation myocardial infarction within 48 hours prior to randomization. · Prior CABG within previous 4 weeks of randomization. · Cardiogenic shock. · Postoperative need for vasopressor and/or inotropic support postoperatively
3. Prior or concomitant therapy. · Concurrent treatment with warfarin.
4. Hemorrhage risk · History of bleeding diathesis or evidence of active abnormal bleeding within 30 days of randomization. · Known haemophilia or thrombocytopathy (Glanzman´s thrombastenia, Bernard-Souliers sdm) · History of hemorrhagic stroke at any time or stroke or TIA of any etiology within 30 days of randomization. · Major surgery within 6 weeks prior to randomization. · Known platelet count of <150,000/mm3. · PT > 1.5 x control · HCT < 25% · Clinical signs of ongoing bleeding at time of inclusion (occult or overt)
5. General · Known allergy or contraindication to aspirin or clopidogrel. · Participation in a study of experimental therapy or device within prior 30 days. · Creatinine level of greater than 4.0 mg/dl. · Liver disease evidenced by ASAT/ALAT > 1.5 times normal · Known history of alcohol or drug abuse. · Pregnant women or women of child-bearing potential.
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E.5 End points |
E.5.1 | Primary end point(s) |
· Graft patency evaluated by MSCT 3 months postoperatively |
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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) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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
| 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 18 |