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

NCT01135667 | Completed Phase 4 DMC

• 1 other identifier: TAILOR
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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)

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndromes

Keywords

clopidogrel; prasugrel; low responder; multiplate; verify now

Outcome Measures

Primary Outcomes (1)

• Heparin ADP by Multiplate

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

  30 days

Study Arms (2)

clopidogrel

ACTIVE COMPARATOR

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

Drug: clopidogrel

Prasugrel

ACTIVE COMPARATOR

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

Drug: Prasugrel 10 mg

Interventions

clopidogrel DRUG

clopidogrel 150 mg once daily for 30 days

Also known as: Plavix

clopidogrel

Prasugrel 10 mg DRUG

Prasugrel 10 mg once daily for 30 days

Also known as: Efient

Prasugrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lene Holmvang: lead

Study Sites (1)

Rigshospitalet, Department of Cardiology, 2013

Copenhagen O, 2100, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

Study Officials

• Lene Holmvang, MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD DMSc

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: June 3, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

DK (1)