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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01203696
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Ruttonjee Hospital

Tracking Information
First Submitted Date  ICMJE September 15, 2010
First Posted Date  ICMJE September 16, 2010
Last Update Posted Date June 6, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Platelet reactivity unit [ Time Frame: baseline and 4 th week ]
Platelet reactivity unit as measured by VerifyNow system
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2012)
Percentage inhibition of platelet activity [ Time Frame: baseline and 4th week ]
Percentage inhibition of platelet activity measured by VerifyNow system
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Percentage ihibition of platelet activity [ Time Frame: baseline and 4th week ]
Percentage inhibition of platelet activity mesaured by verifynow system
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Amlodipine on Anti-platelet Drug Effect in Patients With Coronary Artery Disease
Official Title  ICMJE Effect of Amlodipine on Platelet Inhibition by Clopidogrel in Patients With Ischemic Heart Disease- a Prospective Randomized Controlled Trial
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE
  • Drug: Amlodipine
    For patient with suboptimal angina control: oral 2.5-10mg daily
    Other Name: Norvasc
  • Drug: Amlodipine
    For patient with suboptimal BP control: 2.5-10mg daily po
    Other Name: Norvasc
Study Arms  ICMJE
  • Active Comparator: non-amlodipine
    For patient with suboptimal angina control: anti-anginal agent excluding calcium channel blocker
    Intervention: Drug: Amlodipine
  • Active Comparator: non - amlodipine
    For patient with suboptimal BP control: anti-hypertensive agent excluding calcium channel blocker
    Intervention: Drug: Amlodipine
Publications * Li AY, Ng FH, Chan FK, Tunggal P, Chan K, Lau YK. Effect of amlodipine on platelet inhibition by clopidogrel in patients with ischaemic heart disease: a randomised, controlled trial. Heart. 2013 Apr;99(7):468-73. doi: 10.1136/heartjnl-2012-302801. Epub 2012 Oct 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2012)
97
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2010)
120
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01203696
Other Study ID Numbers  ICMJE Aml-Clo-protocol-v1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruttonjee Hospital
Study Sponsor  ICMJE Ruttonjee Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew YW Li, MB Ruttonjee Hospital
PRS Account Ruttonjee Hospital
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP