Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT01603082
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed 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)

Study Timeline

• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-22
• Study Start: 2012-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-06-01
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-09
• Last Update Submitted: 2015-11-09
• Results First Posted: 2015-12-11
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	Ticagrelor - 180 mg loading dose
Clopidogrel	Clopidogrel	Clopidogrel - 600 mg loading dose

Primary Outcome Measures

Name	Time	Method
Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™	2 hours after the loading dose	Participants with low (\<150) baseline PRU values were excluded.

Secondary Outcome Measures

Name	Time	Method
Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™	0.5 hours, end of PCI, and 8 hours after the loading dose	Participants with low (\<150) baseline PRU values were excluded.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Richmond, Virginia, United States