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Completed

NCT Number: NCT01135667

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

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)

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Acute Coronary Syndromes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Department of Cardiology, 2013

Copenhagen O, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

clopidogrel 150 mg once daily for 30 days

Other names: Plavix

prasugrel 10 mg

Drug

Prasugrel 10 mg once daily for 30 days

Other names: Efient

Primary outcomes

  1. Heparin ADP by Multiplate

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Lene Holmvang

Other

Registry information

Official study title

Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention

Acronym: TAILOR

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2010
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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