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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of clopidogrel and acetylsalicylic acid (ASA) versus clopidogrel or ASA alone on brachial flow mediated vasodilation in patients with coronary artery disease |
| 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 |
| Acronym | CASSANDRA |
| Serial number at source | N/A |
| Study hypothesis | Treatment with clopidogrel 75 mg per day improves brachial artery flow-mediated dilation of patients with coronary artery disease. |
| Lay summary | |
| Ethics approval | Local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) approved on the 20th December 2004 |
| Study design | Prospective double-blind randomised single-centre three-armed phase IV clinical trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Stable coronary artery disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 10/04/2006 |
| Anticipated end date | 06/06/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 120 |
| 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. |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | Bristol-Myers Squibb GmbH & Co. KGaA (Germany) |
| Trial website | |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20644943 |
| Contact name | Dr Ascan Warnholtz |
| Address |
Department of Medicine II
Johannes Gutenberg-University Mainz Langenbeckstrasse 1 |
| City/town | Mainz |
| Zip/Postcode | 55131 |
| Country | Germany |
| Sponsor | Johannes Gutenberg-University Mainz (Johannes Gutenberg-Universitat Mainz) (Germany) |
| Address | Langenbeckstrasse 1 |
| City/town | Mainz |
| Zip/Postcode | 55101 |
| Country | Germany |
| Sponsor website: | http://www.klinik.uni-mainz.de/2-Med/ |
| Date applied | 13/12/2009 |
| Last edited | 19/05/2011 |
| Date ISRCTN assigned | 06/01/2010 |
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