Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Clopidogrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603082

D5130L00014

Details and patient eligibility

About

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Full description

A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

Enrollment: 343 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent before initiation of any study-related procedures
• Male or female patients aged 18 years or older
• Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
• Females must be post menopausal or surgically sterile
• Taking aspirin as an anti-platelet medication

Exclusion criteria

• Use of any thienopyridine or ticagrelor within 7 days prior to randomization
• Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
• Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
• History of intolerance or allergy to aspirin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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343 participants in 2 patient groups

Ticagrelor

Experimental group

Description:

Ticagrelor - 180 mg loading dose

Treatment:

Drug: Ticagrelor

Clopidogrel

Active Comparator group

Description:

Clopidogrel - 600 mg loading dose

Treatment:

Drug: Clopidogrel