Ischemic Heart DiseasePhase 4NCT01203696
Effect of Amlodipine on Anti-platelet Drug Effect in Patients With Coronary Artery Disease
A Phase 4 study testing Amlodipine in people with Ischemic Heart Disease, run by Ruttonjee Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Apr 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Amlodipine on Platelet Inhibition by Clopidogrel in Patients With Ischemic Heart Disease- a Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Amlodipine
- Keywords
- Clopidogrel, Platelet reactivity, Amlodipine
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Also called Norvasc
For patient with suboptimal angina control: oral 2.5-10mg daily
AmlodipineDrug
Also called Norvasc
For patient with suboptimal BP control: 2.5-10mg daily po
| Study group | Role | What they receive |
|---|---|---|
| non-amlodipine | Active comparator | For patient with suboptimal angina control: anti-anginal agent excluding calcium channel blocker Receives: Drug: Amlodipine |
| non - amlodipine | Active comparator | For patient with suboptimal BP control: anti-hypertensive agent excluding calcium channel blocker Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity unit
Platelet reactivity unit as measured by VerifyNow system
Measured: baseline and 4 th week
Secondary outcomes (1)
Percentage inhibition of platelet activity
Percentage inhibition of platelet activity measured by VerifyNow system
Measured: baseline and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruttonjee Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew YW Li, MB, Principal investigator, Ruttonjee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203696
- Sponsor's protocol ID
- Aml-Clo-protocol-v1
- Status last verified
- Jun 2012
- First submitted
- 15 Sep 2010
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23118347
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amlodipine on Platelet Inhibition by Clopidogrel in Patients With Ischemic Heart Disease- a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01203696
- Acronym / sponsor ID
- Aml-Clo-protocol-v1
- Conditions
- Ischemic Heart Disease
- Keywords
- Clopidogrel, Platelet reactivity, Amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Ruttonjee HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 16 Sep 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-amlodipine | Active comparator | Drug: AmlodipineFor patient with suboptimal angina control: anti-anginal agent excluding calcium channel blocker |
| non - amlodipine | Active comparator | Drug: AmlodipineFor patient with suboptimal BP control: anti-hypertensive agent excluding calcium channel blocker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- existing use of amlodipine
- thrombocytopenia
- end stage renal failure
- allergy to clopidogrel/ amlodipine
- pregnancy/ lactation
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 |
|---|---|---|
| AmlodipineAlso: NorvascFor patient with suboptimal angina control: oral 2.5-10mg daily | Drug | non-amlodipine |
| AmlodipineAlso: NorvascFor patient with suboptimal BP control: 2.5-10mg daily po | Drug | non - amlodipine |
Primary outcome
Platelet reactivity unit
Time frame: baseline and 4 th week
Platelet reactivity unit as measured by VerifyNow system
1 secondary outcome
Percentage inhibition of platelet activity
Time frame: baseline and 4th week
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 6 Jun 2012.
- Derived from this study: PubMed 23118347Li 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.
Related trials for Ischemic Heart Disease
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
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.
Andrew YW Li, MB principal investigator
Ruttonjee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine in people with Ischemic Heart Disease, run by Ruttonjee Hospital at 1 site in China.
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 3 inclusion and 6 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Platelet reactivity unit (time frame: baseline and 4 th week). 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 NCT01203696, which also lists 1 linked publication.
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 6 Jun 2012.