Pharmacodynamic Effects of Ranolazine Versus Amlodipine o... | NCT01490255

Studies
Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

NCT01490255

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Mar 26, 2014Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Ranolazine
Amlodipine

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Dec 8, 2011

First Submission Date that Met QC Criteria

Dec 9, 2011

First Posted Date

Dec 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2014

Last Update Posted Date

Mar 26, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesco Pelliccia, Assistant Professor, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

No previous study has assessed the potential of ranolazine to interfere with levels of platelet reactivity in patients with coronary artery disease who are treated with dual antiplatelet therapy.

Aim of this study is to compare the pharmacodynamic effects of maintenance doses of ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease who are treated with dual antiplatelet therapy.

Detailed Description

Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy (DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events.

Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel, such as calcium channel blockers, potentially interfering with its clinical benefits. Importantly, calcium channel blockers, such as amlodipine, are commonly used for relief of ischemic symptoms in patients with CAD.

Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation and constitutes a pharmacologic alternative to calcium channel blockade.

However, no previous study has assessed the potential of ranolazine to interfere with levels of platelet reactivity in CAD patients on DAT.

The primary objective of this study is to compare the pharmacodynamic effects of maintenance doses of ranolazine versus amlodipine on platelet reactivity in patients with CAD on DAT.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranolazine	Active Comparator	Patients will receive ranolazine (750 mg bid) for 15 days	Drug: Ranolazine
Amlodipine	Active Comparator	Patients will receive amlodipine (10 mg once daily) for 15 days	Drug: Amlodipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ranolazine	Drug	os, 750 mg, twice per day, for 15 days	Ranolazine	Ranexa®, Gilead, USA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of platelet reaction units	Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California])	After 15 days of treatment with each drug

Secondary Outcomes

Measure	Description	Time Frame
Frequency of high platelet reactivity	Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240	After 15 days of treatment with each drug

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Angiographically-proven coronary artery disease
Class I indication to dual antiplatelet therapy because of recent (<12 months) percutaneous coronary intervention and/or recent acute coronary syndrome (<12 months)
Stable clinical conditions
Able to understand and willing to sign the informed consent form

Exclusion Criteria:

Use of other drug interfering with CYP activity such as proton pump inhibitors
Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Pelliccia, MD	Contact	+393483392006		f.pelliccia@mclink.it

Overall Officials

Name	Affiliation	Role
Francesco Pelliccia, MD	University La Sapienza, Rome, IT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Raffaele Pisana	Recruiting	Rome		00100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069458	Ranolazine
D017311	Amlodipine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided