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Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI

NCT ID: NCT01135667

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

Brief Summary

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All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.

A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age \> 75 og bodyweight \< 60 kg 5 mg)once daily for 30 days after the procedure.

Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.

Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.

Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)

Detailed Description

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Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention Acute Coronary Syndromes

Keywords

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clopidogrel prasugrel low responder multiplate verify now

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clopidogrel

clopidogrel 150 mg once daily for 30 days (and then 75 mg for additional 11 months - not study related)

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

clopidogrel 150 mg once daily for 30 days

Prasugrel

Prasugrel 10 mg once daily for 30 days (and then clopidogrel 75 mg once daily for additional 11 months - not study related)

Group Type ACTIVE_COMPARATOR

Prasugrel 10 mg

Intervention Type DRUG

Prasugrel 10 mg once daily for 30 days

Interventions

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clopidogrel

clopidogrel 150 mg once daily for 30 days

Intervention Type DRUG

Prasugrel 10 mg

Prasugrel 10 mg once daily for 30 days

Intervention Type DRUG

Other Intervention Names

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Plavix Efient

Eligibility Criteria

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Inclusion Criteria

* PCI with stenting and Multiplate hep-ADP \> 70 U despite clopidogrel loading

Exclusion Criteria

* need for vit K antagonist
* women with childbearing potential
* breastfeeding women
* Planned surgery within 6 months
* Intolerance to clopidogrel, prasugrel or aspirin
* previous stroke
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lene Holmvang

OTHER

Sponsor Role lead

Responsible Party

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Lene Holmvang

MD DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lene Holmvang, MD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Department of Cardiology, 2013

Copenhagen O, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TAILOR

Identifier Type: -

Identifier Source: org_study_id