Effect of clopidogrel and acetylsalicylic acid (ASA) versus clopidogrel or ASA alone on brachial flow mediated vasodilation in patients with coronary artery disease
| ISRCTN | ISRCTN34097747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34097747 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/12/2009
- Registration date
- 06/01/2010
- Last edited
- 19/05/2011
- 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
Department of Medicine II
Johannes Gutenberg-University Mainz
Langenbeckstrasse 1
Mainz
55131
Germany
Study information
| Study design | Prospective double-blind randomised single-centre three-armed phase IV clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of clopidogrel and acetylsalicylic acid (ASA) versus clopidogrel or ASA alone on brachial flow mediated vasodilation in patients with coronary artery disease: a prospective, double-blind, randomised, single-centre trial |
| Study acronym | CASSANDRA |
| Study objectives | Treatment with clopidogrel 75 mg per day improves brachial artery flow-mediated dilation of patients with coronary artery disease. |
| Ethics approval(s) | Local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) approved on the 20th December 2004 |
| Health condition(s) or problem(s) studied | Stable coronary artery disease |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Clopidogrel, acetylsalicylic acid (ASA) |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 10/04/2006 |
| Completion date | 06/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/04/2006 |
| Date of final enrolment | 06/06/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Medicine II
Mainz
55131
Germany
55131
Germany
Sponsor information
Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany)
University/education
University/education
Langenbeckstrasse 1
Mainz
55101
Germany
| Website | http://www.klinik.uni-mainz.de/2-Med/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/01/2011 | Yes | No |
