Stable coronary artery disease Circulatory System Ischaemic heart diseases
Conditions
Interventions
Single dose of 300 mg versus 600 mg of clopidogrel orally.
Sponsors
Johannes Gutenberg-Universität Mainz (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women, older than 18 years of age 2. Angiographically documented, clinically stable coronary artery disease (defined as at least one coronary artery stenosis more than 50% or general wall irregularities) 3. Endothelial dysfunction, defined as a Flow-Mediated Vasodilatation (FMD) of less than 8% 4. Ability of subject to understand character and individual consequences of clinical trial 5. Written informed consent must be available before enrolment in the trial 6. Current therapy with acetylsalicylic acid 100 mg/d
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome 2. Clinical signs of congestive heart failure or left ventricular ejection fraction less than 40% 3. Uncontrolled hypertension (blood pressure more than 180/105 mmHg) or hypotension (systolic blood pressure less than 90 mmHg) 4. Treatment with clopidogrel or ticlopidine within the last 28 days prior to study start 5. Haemodynamically significant valvular heart disease 6. Renal dysfunction (creatinine more than 2.0 mg/dl) 7. History of chronic liver disease or pancreatitis 8. Alcohol abuse 9. Haemoglobin less than 12 g/dl, White Blood Cells (WBC) less than 4/nl or platelet count less than 100/nl 10. Existence of acute gastric ulcers or acute gastrointestinal bleeding 11. Chronic inflammatory intestinal disease or history of malabsorption 12. Known hyper- or hypothyroidism 13. Anticipated non-compliance with the protocol 14. Pregnancy 15. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of treatment on the absolute change in % Flow-Mediated Dilation (FMD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of treatment on: 1. Platelet superoxide production 2. Platelet basal VAsodilator-Stimulated Phosphoprotein (VASP)-phosphorylation 3. Platelet P2V12-receptor inhibition | — |
Countries
Germany
Outcome results
None listed