E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10035523 |
E.1.2 | Term | Platelet analyses |
|
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 | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
|
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 aim of this study is to identify whether there is evidence for a "rebound" effect on platelet markers associated with cessation of clopidogrel therapy. We propose to address this in patients with stable cardiovascular disease by means of a mechanistic study.
|
|
E.2.2 | Secondary objectives of the trial |
We will also assess the effect of withdrawal of clopidogrel on inflammatory and procoagulant markers as another possible mechanism for increased risk of cardiovascular ischaemic events.
While the primary aim of this study is not to measure clinical outcome, these data will be collected for a period of 6 months following completion of the study. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged between 30-80 yrs with evidence of chronic atherosclerotic disease - stable coronary heart disease or peripheral arterial disease. All subjects will already be receiving standard secondary preventive therapy including aspirin therapy and a statin. |
|
E.4 | Principal exclusion criteria |
Patients will be excluded if they have a known allergy to clopidogrel, have a history of thrombocytopenia, neutropenia, haematological malignancy, abnormal renal or hepatic function, transfusion of whole blood cells within 14 days prior to randomisation, known or suspected drug or alcohol abuse, bleeding diathesis, or clinical symptoms of heart failure. Women of child-bearing potential will be excluded. Patients taking other antiplatelet drugs other than aspirin, or taking anticoagulant drugs will be excluded.
Concurrent use of proton pump inhibitors (amendment AM005 November 2009). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be a rebound effect (∆A) in platelet response to stimulation, within the clopidogrel treatment group compared with the placebo group. ∆A is calculated by subtracting the subject's platelet activity at baseline (A(tb)) from the activity at follow-up (A(tf)). We will also compare the mean ∆A in the clopidogrel treatment group with the mean in the placebo group using unpaired t-tests . ∆A is expected to be close to zero in the placebo group but these patients are included to control for any unexpected shift in patient response.
|
|
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 | Yes |
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
| 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
|
The end of the trial will be defined as the date when the last patients has completed the study protocol. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 | 2 |