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

NCT ID: NCT01090336

Last Updated: 2011-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Detailed Description

look above

Conditions

Patients With Acute Coronary Syndrome

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Clopidogrel group

At the discretion of the attending cardiologist patients are treated with clopidogrel (600mg loading and 75mg daily dose)

No interventions assigned to this group

Prasugrel group

At the discretion of the attending cardiologist patients are treated with prasugrel (60mg loading and 10mg daily dose)

No interventions assigned to this group

Eligibility 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Department of Cardiology, University of Heidelberg

Principal Investigators

Evangelos Giannitsis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, University of Heidelberg

Locations

University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Evangelos Giannitsis, Prof. Dr.

Role: primary

Evangelos_Giannitsis@med.uni-heidelberg.de

+49 (0)6221-56-8611

References

Ivandic BT, Schlick P, Staritz P, Kurz K, Katus HA, Giannitsis E. Determination of clopidogrel resistance by whole blood platelet aggregometry and inhibitors of the P2Y12 receptor. Clin Chem. 2006 Mar;52(3):383-8. doi: 10.1373/clinchem.2005.059535. Epub 2006 Jan 19.

Reference Type: RESULT

PMID: 16423907 (View on PubMed)

Other Identifiers

S-235/2009

Identifier Type: OTHER

Identifier Source: secondary_id

PC01

Identifier Type: -

Identifier Source: org_study_id