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

Coronary Artery Disease Clinical Trial

— TAILOR  

Official title:

Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135667
• Other study ID #: TAILOR
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2010
• Last updated: October 3, 2012
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• clopidogrel
clopidogrel 150 mg once daily for 30 days
• Prasugrel 10 mg
Prasugrel 10 mg once daily for 30 days

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Department of Cardiology, 2013	Copenhagen O

Sponsors (1)

Lead Sponsor	Collaborator
Lene Holmvang

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heparin ADP by Multiplate	Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy	30 days	No