Effects of Clopidogrel on Blood Pressure

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01112137
• Date of registration: 26/04/2010
• Primary sponsor: University of Cologne
• Public title: Effects of Clopidogrel on Blood Pressure
• Scientific title: Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure
• Date of first enrolment: January 2005
• Target sample size: 46
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01112137
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Germany, Netherlands

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with coronary artery disease (CAD) and a clinical presentation of stable
angina pectoris or acute coronary syndrome who had undergone percutaneous coronary
intervention (PCI) with stent implantation

- 5-year history of essential arterial hypertension with a systolic BP between 140 and
170 mmHg or no hypertension (systolic BP <140mg Hg and diastolic BP <90 mmHg)

- treatment with clopidogrel (75 mg per day) for 6 to 12 months after PCI

- continuous use of aspirin (100 mg per day)

- no change in drug therapy within 3 months prestudy

Exclusion Criteria:

- stent thrombosis or another ischemic cardiovascular event following PCI

- use of other antiplatelet drugs or anticoagulants within 3 months prestudy

- surgery within 3 months prestudy

- arrhythmia

- valvular heart disease

- hematologic disorder

- severe renal disorder

- severe hepatic disorder

- chronic inflammatory disorder

- autoimmune disorder

- acute or chronic infection

- active malignancy

- a body-mass index below 18.5 or above 40 kg/m2

- nonadherence to therapy

- nonattendance to control visits



Age minimum: 45 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Blood Pressure

Endothelial Function

Platelet Function

Intervention(s)

Drug: Clopidogrel

Primary Outcome(s)

blood pressure [Time Frame: No]

Secondary Outcome(s)

markers of platelet and endothelial function [Time Frame: No]

Secondary ID(s)

NLN5031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors