Blood PressurePhase 4NCT01112137
Effects of Clopidogrel on Blood Pressure
A Phase 4 study testing Clopidogrel in people with Blood Pressure and Endothelial Function, run by University of Cologne at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Blood Pressure, Endothelial Function, Platelet Function
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2005to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure
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.
Read more
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
- Blood Pressure, Endothelial Function, Platelet Function
- Being tested
- Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
ClopidogrelDrug
ClopidogrelDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive individuals: clopidogrel (600 mg, bolus) | Experimental | Not described Receives: Drug: Clopidogrel |
| Hypertensive individuals: clopidogrel (75 mg daily) | Experimental | Not described Receives: Drug: Clopidogrel |
| Normotensive individuals: clopidogrel (600 mg, bolus) | Active comparator | Not described Receives: Drug: Clopidogrel |
| Normotensive individuals: clopidogrel (75 mg, daily) | Active comparator | Not described Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Secondary outcomes (1)
markers of platelet and endothelial function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112137
- Sponsor's protocol ID
- NLN5031
- Status last verified
- Apr 2010
- First submitted
- 26 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
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 12646667Heitzer 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 16675725Henn 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 9468137Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Effects of Clopidogrel on Soluble CD40 Ligand, Endothelial Function and Blood Pressure
- ClinicalTrials.gov ID
- NCT01112137
- Acronym / sponsor ID
- NLN5031
- Conditions
- Blood Pressure, Endothelial Function, Platelet Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypertensive individuals: clopidogrel (600 mg, bolus) | Experimental | Drug: Clopidogrel |
| Hypertensive individuals: clopidogrel (75 mg daily) | Experimental | Drug: Clopidogrel |
| Normotensive individuals: clopidogrel (600 mg, bolus) | Active comparator | Drug: Clopidogrel |
| Normotensive individuals: clopidogrel (75 mg, daily) | Active comparator | Drug: Clopidogrel |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel | Drug | Hypertensive individuals: clopidogrel (600 mg, bolus) |
| Clopidogrel | Drug | Hypertensive individuals: clopidogrel (75 mg daily) |
| Clopidogrel | Drug | Normotensive individuals: clopidogrel (600 mg, bolus) |
| Clopidogrel | Drug | Normotensive individuals: clopidogrel (75 mg, daily) |
Primary outcome
blood pressure
1 secondary outcome
markers of platelet and endothelial function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Background: PubMed 12646667Heeschen 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.
- Background: PubMed 16675725Heitzer 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.
- Background: PubMed 9468137Henn 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.
- Background: PubMed 18658029Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Blood Pressure and Endothelial Function, run by University of Cologne at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112137, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2010.