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
Secondary identifying numbers N/A
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

Johannes Gutenberg-Universität Mainz
Department of Medicine II
Langenbeckstrasse 1
Mainz
55101
Germany

Study information

Study designA prospective, double-blind, randomised, single-center, two-armed clinical trial of phase IV.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect of clopidogrel loading dose on brachial flow mediated vasodilation in patients with coronary artery disease
Study acronymCLEOPATRA
Study objectivesOne 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) studiedStable coronary artery disease
InterventionSingle dose of 300 mg versus 600 mg of clopidogrel orally.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Clopidogrel
Primary outcome measureEffect of treatment on the absolute change in % Flow-Mediated Dilation (FMD).
Secondary outcome measuresEffects of treatment on:
1. Platelet superoxide production
2. Platelet basal VAsodilator-Stimulated Phosphoprotein (VASP)-phosphorylation
3. Platelet P2V12-receptor inhibition
Overall study start date01/03/2005
Completion date02/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants58
Total final enrolment58
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2005
Date of final enrolment02/02/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Johannes Gutenberg-Universität Mainz
Mainz
55101
Germany

Sponsor information

Johannes Gutenberg-Universität Mainz (Germany)
University/education

c/o Prof. Dr. T. Münzel
Department of Medicine II
Langenbeckstrasse 1
Mainz
55101
Germany

Website http://www.klinik.uni-mainz.de/2-Med/
ROR logo "ROR" https://ror.org/023b0x485

Funders

Funder type

Industry

Bristol-Myers Squibb GmbH & Co. KGaA (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.