CompletedNCT01112137Updated Apr 28, 2010

Effects of Clopidogrel on Blood Pressure

A Phase 4 interventional study of Clopidogrel and Clopidogrel in Blood Pressure, Endothelial Function and Platelet Function, sponsored by University of Cologne. Completed at 2 sites in 2 countries. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-04-28.

Sponsored by University of Cologne · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 45 Years to 75 Years
Sex: All

Study summary

Context: Soluble CD40 ligand (sCD40L) released from activated platelets induces inflammatory transformation of the vascular endothelium and is an independent predictor of cardiovascular events. Arterial hypertension is associated with platelet activation, increased sCD40L levels and endothelial dysfunction suggesting that inhibition of platelet-derived sCD40L release may improve endothelial function and lower blood pressure (BP).

Objective: To determine the effects of clopidogrel on sCD40L, endothelial function and BP.

Design: Randomized, controlled, investigator-blinded, parallel-group, 2-phase trial in patients with coronary artery disease and essential arterial hypertension and those without hypertension.

Intervention: Participants receive a single 600-mg clopidogrel loading dose (phase I) followed by a daily 75-mg clopidogrel maintenance dose over 28 days (phase II).

Outcome Measures: Primary outcome measure is the change in BP from baseline. Secondary outcome measures are changes in biomarkers of platelet and endothelial function and their correlation with BP.

Conditions studied

Blood Pressure
Endothelial Function
Platelet Function

In context

Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 46 participants (actual)

Study arms

Experimental
Hypertensive individuals: clopidogrel (600 mg, bolus)
Drug: Clopidogrel
Experimental
Hypertensive individuals: clopidogrel (75 mg daily)
Drug: Clopidogrel
Active comparator
Normotensive individuals: clopidogrel (600 mg, bolus)
Drug: Clopidogrel
Active comparator
Normotensive individuals: clopidogrel (75 mg, daily)
Drug: Clopidogrel

Interventions

What researchers measure

Primary outcomes

blood pressure

Secondary outcomes

markers of platelet and endothelial function

Study locations

2 sites

University of Cologne
Cologne, D-50931, Germany
St Antonius Hospital Nieuwegein
Nieuwegein, 3435 CM, Netherlands

References and documents

Publications

Heeschen C, Dimmeler S, Hamm CW, van den Brand MJ, Boersma E, Zeiher AM, Simoons ML; CAPTURE Study Investigators. Soluble CD40 ligand in acute coronary syndromes. N Engl J Med. 2003 Mar 20;348(12):1104-11. doi: 10.1056/NEJMoa022600. PubMed 12646667 ↗
Heitzer T, Rudolph V, Schwedhelm E, Karstens M, Sydow K, Ortak M, Tschentscher P, Meinertz T, Boger R, Baldus S. Clopidogrel improves systemic endothelial nitric oxide bioavailability in patients with coronary artery disease: evidence for antioxidant and antiinflammatory effects. Arterioscler Thromb Vasc Biol. 2006 Jul;26(7):1648-52. doi: 10.1161/01.ATV.0000225288.74170.dc. Epub 2006 May 4. PubMed 16675725 ↗
Henn V, Slupsky JR, Grafe M, Anagnostopoulos I, Forster R, Muller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4. doi: 10.1038/35393. PubMed 9468137 ↗
Chen C, Chai H, Wang X, Jiang J, Jamaluddin MS, Liao D, Zhang Y, Wang H, Bharadwaj U, Zhang S, Li M, Lin P, Yao Q. Soluble CD40 ligand induces endothelial dysfunction in human and porcine coronary artery endothelial cells. Blood. 2008 Oct 15;112(8):3205-16. doi: 10.1182/blood-2008-03-143479. Epub 2008 Jul 24. PubMed 18658029 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005, a primary completion of Dec 2009 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 26, 2010
First posted: Apr 28, 2010
Start: Jan 2005
Primary completionActual: Dec 2009
CompletionActual: Apr 2010
Last update: Apr 28, 2010

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01112137
Lead sponsor: University of Cologne
First posted: Apr 28, 2010
Start date: Jan 2005
Primary completion: Dec 2009
Completion: Apr 2010
Last update: Apr 28, 2010

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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