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

Primary Purpose

Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

clopidogrel

Prasugrel 10 mg

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring clopidogrel, prasugrel, low responder, multiplate, verify now

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rigshospitalet, Department of Cardiology, 2013

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

clopidogrel

Prasugrel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Heparin ADP by Multiplate

Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy

Secondary Outcome Measures

Full Information

NCT ID

NCT01135667

First Posted

April 23, 2010

Last Updated

October 3, 2012

Sponsor

Lene Holmvang

1. Study Identification

Unique Protocol Identification Number

NCT01135667

Brief Title

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

Acronym

TAILOR

Official Title

Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lene Holmvang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes

Keywords

clopidogrel, prasugrel, low responder, multiplate, verify now

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

clopidogrel

Arm Type

Active Comparator

Arm Description

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

Arm Title

Prasugrel

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

clopidogrel 150 mg once daily for 30 days

Intervention Type

Drug

Intervention Name(s)

Prasugrel 10 mg

Other Intervention Name(s)

Efient

Intervention Description

Prasugrel 10 mg once daily for 30 days

Primary Outcome Measure Information:

Title

Heparin ADP by Multiplate

Description

Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lene Holmvang, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Director

Facility Information:

Facility Name

Rigshospitalet, Department of Cardiology, 2013

City

Copenhagen O

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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