Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

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

Detailed Description
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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)

Official Title
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A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>Ticagrelor - 180 mg loading dose | Drug: Ticagrelor<br>* 180 mg loading dose<br>|
| Active Comparator: Clopidogrel<br>Clopidogrel - 600 mg loading dose | Drug: Clopidogrel<br>* 600 mg loading dose<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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™ | Participants with low (<150) baseline PRU values were excluded. | 0.5 hours, end of PCI, and 8 hours after the loading dose |