Effect of clopidogrel loading dose on brachial flow mediated vasodilation in patients with coronary artery disease
| ISRCTN | ISRCTN17892444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17892444 |
| Protocol serial number | N/A |
| Sponsor | Johannes Gutenberg-Universität Mainz (Germany) |
| Funder | Bristol-Myers Squibb GmbH & Co. KGaA (Germany) |
- Submission date
- 30/11/2006
- Registration date
- 06/12/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ascan Warnholtz
Scientific
Scientific
Johannes Gutenberg-Universität Mainz
Department of Medicine II
Langenbeckstrasse 1
Mainz
55101
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective, double-blind, randomised, single-center, two-armed clinical trial of phase IV. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of clopidogrel loading dose on brachial flow mediated vasodilation in patients with coronary artery disease |
| Study acronym | CLEOPATRA |
| Study objectives | One single dose of clopidogrel causes dose-dependent improvement of flow-mediated dilation to the right brachial artery in patients with stable coronary artery disease. |
| Ethics approval(s) | Approval received from the local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz), dated Dec 20th, 2004 (ref: 837.473.04 [4631]). |
| Health condition(s) or problem(s) studied | Stable coronary artery disease |
| Intervention | Single dose of 300 mg versus 600 mg of clopidogrel orally. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Clopidogrel |
| Primary outcome measure(s) |
Effect of treatment on the absolute change in % Flow-Mediated Dilation (FMD). |
| Key secondary outcome measure(s) |
Effects of treatment on: |
| Completion date | 02/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 58 |
| Total final enrolment | 58 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 02/02/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Johannes Gutenberg-Universität Mainz
Mainz
55101
Germany
55101
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
