Effect of Amlodipine on Anti-platelet Drug Effect in Patients With Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruttonjee Hospital
ClinicalTrials.gov Identifier:
NCT01203696
First received: September 15, 2010
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

Clopidogrel can reduce risk of cardiovascular disease by inhibiting platelet aggregation. It is metabolized to an active drug by a liver enzyme. Its efficacy may be measured by blood sampling for platelet activity, analyzed by VerifyNow device. Calcium Channel blocker (CCB) is also commonly used for blood pressure and anginal control in these patients. Dihydropyridine group of calcium channel blocker (e.g. amlodipine) inhibits this enzyme. There are observational studies reporting dihydropyridine CCB reducing clopidogrel effect, but the clinical implication is unclear.

This study test the hypothesis that there is no significant effect of dihydropyridines CCB on clopidogrel response compared with control. After giving consent, patients with suboptimal blood pressure or anginal control will be randomized to receive either dihydropyridine CCB or non-CCB as placebo. These patient will be follow-up in 1 month.


Condition Intervention Phase
Ischemic Heart Disease
Drug: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Amlodipine on Platelet Inhibition by Clopidogrel in Patients With Ischemic Heart Disease- a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ruttonjee Hospital:

Primary Outcome Measures:
  • Platelet reactivity unit [ Time Frame: baseline and 4 th week ] [ Designated as safety issue: No ]
    Platelet reactivity unit as measured by VerifyNow system


Secondary Outcome Measures:
  • Percentage inhibition of platelet activity [ Time Frame: baseline and 4th week ] [ Designated as safety issue: No ]
    Percentage inhibition of platelet activity measured by VerifyNow system


Enrollment: 97
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: non-amlodipine
For patient with suboptimal angina control: anti-anginal agent excluding calcium channel blocker
Drug: Amlodipine
For patient with suboptimal angina control: oral 2.5-10mg daily
Other Name: Norvasc
Active Comparator: non - amlodipine
For patient with suboptimal BP control: anti-hypertensive agent excluding calcium channel blocker
Drug: Amlodipine
For patient with suboptimal BP control: 2.5-10mg daily po
Other Name: Norvasc

Detailed Description:

Clopidogrel is a pro-drug, which requires hepatic transformation by the cytochrome P450 isoform 3A4 to generate the active metabolite. It inhibits adenosine-5-diphosphate (ADP)-induced platelet aggregation by irreversibly blocking the platelet P2Y12 receptor. However, response to clopidogrel shows wide individual variability, and patients with high on-treatment residual ADP-induced platelet reactivity are at an increased risk of adverse cardiovascular events. Previous study suggest co-administration of CCBs is associated with decreased platelet inhibition by clopidogrel, but these observational studies are confounded by patient's characteristics baseline difference such as proportion of hypertension and diabetes.

The objective of this randomized controlled study is to compare amlodipine with placebo on anti-platelet effect of clopidogrel.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ischemic heart disease patient, and
  • given loading or maintenance dose of clopidogrel and in need of it for 1 or more month
  • and in need of additional drug for optimal BP control (aim blood pressure <130/90) or angina control.

Exclusion Criteria:

  • existing use of amlodipine
  • thrombocytopenia
  • end stage renal failure
  • allergy to clopidogrel/ amlodipine
  • pregnancy/ lactation
  • strong inhibitor or inducer of cytochrome P450 3A4 enzyme within 7 days before start of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203696

Locations
China
Ruttonjee Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Ruttonjee Hospital
Investigators
Principal Investigator: Andrew YW Li, MB Ruttonjee Hospital
  More Information

No publications provided by Ruttonjee Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT01203696     History of Changes
Other Study ID Numbers: Aml-Clo-protocol-v1
Study First Received: September 15, 2010
Last Updated: June 5, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Ruttonjee Hospital:
Clopidogrel
Platelet reactivity
Amlodipine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Calcium Channel Blockers
Amlodipine
Clopidogrel
Platelet Aggregation Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Vasodilator Agents
Antihypertensive Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014