Stable coronary artery disease Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
Clopidogrel 75 mg per day versus clopidogrel 75 mg and acetylsalicylic acid 100 mg per day versus acetylsalicylic acid 100 mg per day for 4 weeks.
Sponsors
Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women, older than 18 years of age 2. Angiographically documented coronary artery disease 3. Absence of angina pectoris within the previous four weeks 4. Written informed consent must be available before enrolment in the trial
Exclusion criteria
Exclusion criteria: 1. Stroke or peripheral arterial revascularisation within the previous 12 weeks 2. Clopidogrel intolerance 3. Planned coronary stent implantation within the next 6 weeks 4. Haemodynamically significant valvular heart disease 5. Known hyper- or hypothyroidism 6. Renal dysfunction (creatinine more than 2.0 mg/dl) 7. Chronic inflammatory intestinal disease or history of malabsorption 8. History of chronic liver disease or pancreatitis 9. Existence of acute gastric ulcers or acute gastrointestinal bleeding 10. Haemoglobin less than 12 g/dl, white blood cells (WBC) less than 4/nl or platelet count less than 100/nl 11. History of organ transplantation 12. Anticipated non-compliance with the protocol 13. Pregnancy 14. Participation in another clinical trial 15. Clinical signs of congestive heart failure or left ventricular ejection fraction less than 40% 16. Uncontrolled hypertension (blood pressure more than 180/105 mmHg) 17. Orthostatic hypotension (supine systolic blood pressure less than 90 mmHg) 18. Treatment with clopidogrel or ticlopidine within the last 28 days prior to study start 19. Initiation of treatment with angiotensin converting enzyme (ACE) inhibitor, statin or calcium channel blocker within previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of treatment on the absolute change in % flow-mediated dilation (FMD) of the right brachial artery. Evaluated by measurements at the beginning of the trial and at the end of treatment at day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of treatment on: 1. Platelet superoxide production 2. Adenosine diphosphate (ADP)-induced platelet aggregation 3. Nitroglycerin-induced brachial artery dilation 4. Inflammatory markers Evaluated by measurements at the beginning of the trial and at the end of treatment at day 28. | — |
Countries
Germany
Outcome results
None listed