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Prasugrel Versus Clopidogrel in Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Daiichi Sankyo Europe, GmbH
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01090336
First received: March 16, 2010
Last updated: April 15, 2011
Last verified: March 2010
  Purpose

Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing early PCI remains, at present, unknown.

Study design/study population: This trial is a prospective, open-label, single centre observational trial. Patients receive either prasugrel (60mg) or clopidogrel (600mg) at the discretion of the attending cardiologist. Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well. The study population includes 80 subjects with moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all patients early PCI is planned.

Study objective/endpoint/methods: The primary objective of this trial is to evaluate whether rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early PCI.

The primary endpoint is the rate of drug resistance at time of index intervention. Optical and impedance aggregometry using ADP (5 and 20 μM) and collagen (1 μg/ml) as platelet agonists is used to measure platelet aggregation. Addition of the specific antagonists aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and pharmacokinetic drug resistance.

Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs) during the days following the index event reflecting earlier, more effective and more consistent inhibition of platelet function.

Tertiary endpoint is the composite clinical endpoint of cardiovascular death, nonfatal MI, or stroke and urgent target vessel revascularization during hospitalization and after 6 and 12 months.

Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12 months including intracranial and life-threatening bleeding.


Condition
Patients With Acute Coronary Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prevalence of Inadequate Platelet Inhibition After Oral Loading With Prasugrel/Clopidogrel in Patients With an Acute Coronary Syndrome Undergoing Early PCI

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • The primary endpoint is the rate of drug resistance at time of index intervention. [ Time Frame: Routinely, platelet aggregation is evaluated ideally daily up to 96 hours after index event. ] [ Designated as safety issue: Yes ]
    Platelet aggregation is determined by light transmission and impedance aggregometry as previoulsy described (Boris T. Ivandic, Philipp Schlick, Peter Staritz, Kerstin Kurz, Hugo A. Katus and Evangelos Giannitsis: Determination of Clopidogrel Resistance by Whole Blood Platelet Aggregometry and Inhibitors of the P2Y12 Receptor; Clinical Chemistry 52: 383-388, 2006)


Secondary Outcome Measures:
  • Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs). [ Time Frame: Routinely, ideally daily until 96h after index event. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Groups/Cohorts
Clopidogrel group
At the discretion of the attending cardiologist patients are treated with clopidogrel (600mg loading and 75mg daily dose)
Prasugrel group
At the discretion of the attending cardiologist patients are treated with prasugrel (60mg loading and 10mg daily dose)

Detailed Description:

look above

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population includes 80 subjects with moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of symptoms. In all patients early PCI is planned. Patients with exclusion criteria for prasugrel will be excluded for clopidogrel as well.

Criteria

Inclusion criteria:

  • Patients with unstable angina or non-ST-elevation myocardial infarction with ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization,
  • A TIMI risk score of 3 or more, and
  • Either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis.
  • Legal age (and ≥18 y) and competent mental condition to provide written informed consent

Exclusion Criteria:

  • Patients with weight < 60 kg, age > 75 year or history of TIA, stroke or intracranial bleeding according to prasugrel contraindications
  • Clinical status forbid inclusion (eg cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, New York Heart Association class IV congestive heart failure etc)
  • Bleeding risk exclusion criteria including fibrin-specific and non-fibrin-specific fibrinolytic therapy for index event, active internal bleeding or history of bleeding diathesis or any clinical findings in the judgment of the investigator associated with an increased risk of bleeding
  • History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Ischemic stroke within 3 months prior to screening
  • Oral anticoagulation or INR greater than 1.5 at the time of screening
  • Platelet count of less than 100 000/mm3 at the time of screening
  • Anemia (hemoglobin <10 g/dL) at the time of screening
  • Prior/concomitant therapy with thienopyridine or daily treatment with nonsteroidal antiinflammatory drugs or cyclooxygenase-2 inhibitors
  • General exclusion criteria
  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: NCT01090336

Locations
Germany
University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Evangelos Giannitsis, Prof. Dr.    +49 (0)6221-56-8611    Evangelos_Giannitsis@med.uni-heidelberg.de   
Sub-Investigator: Kerstin Kurz, Dr.         
Sponsors and Collaborators
Heidelberg University
Daiichi Sankyo Europe, GmbH
Investigators
Principal Investigator: Evangelos Giannitsis, Prof. Dr. Department of Cardiology, University of Heidelberg
  More Information

Publications:
Responsible Party: Prof. Dr. Evangelos Giannitsis, Department of Cardiology, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01090336     History of Changes
Other Study ID Numbers: PC01, S-235/2009
Study First Received: March 16, 2010
Last Updated: April 15, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
platelet aggregation inhibition
prasugrel
clopidogrel
ACS

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

ClinicalTrials.gov processed this record on November 19, 2014