Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01109784
First received: April 22, 2010
Last updated: August 23, 2010
Last verified: April 2010
  Purpose

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.


Condition Intervention Phase
Coronary Artery Disease (CAD)
Acute Coronary Syndrome (ACS)
Drug: prasugrel
Drug: clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) [ Time Frame: Day 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prasugrel
prasugrel per os 10mg/day
Drug: prasugrel
prasugrel 10 mg/day
Active Comparator: clopidogrel
clopidogrel per os 150mg/day
Drug: clopidogrel
clopidogrel per os 150mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years old
  • Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
  • Written Informed consent
  • Platelet reactivity units (PRU) (VerifyNow) >230

Exclusion Criteria:

  • A history of bleeding diathesis
  • Chronic oral anticoagulation treatment
  • Contraindications to antiplatelet therapy
  • Known platelet function disorders
  • PCI or coronary artery bypass surgery < 3 months
  • Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
  • Planned staged PCI in the next 60 days
  • Hemodynamic instability
  • Cancer or hemodialysis
  • Platelet count <100 000/ μL, hematocrit <30%
  • Creatinine clearance <25 ml/min
  • A life expectancy<1 year, inability to give informed consent
  • High likelihood of being unavailable for the Day 60 follow up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109784

Locations
Greece
Cardiology Department, Patras University Hospital
Rio, Patras, Greece, 26500
Sponsors and Collaborators
University of Patras
  More Information

No publications provided by University of Patras

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitrios Alexopoulos, Patras University Hospital
ClinicalTrials.gov Identifier: NCT01109784     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-1
Study First Received: April 22, 2010
Last Updated: August 23, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
coronary angioplasty
clopidogrel resistance
prasugrel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Prasugrel
Clopidogrel
Ticlopidine
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014