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OpenTrials
Completed

NCT Number: NCT01603082

Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

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

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Birmingham, Alabama, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

180 mg loading dose

clopidogrel

Drug

600 mg loading dose

Primary outcomes

  1. Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™

    Time frame: 2 hours after the loading dose

    Participants with low (<150) baseline PRU values were excluded.

Secondary outcomes

  1. 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™

    Time frame: 0.5 hours, end of PCI, and 8 hours after the loading dose

    Participants with low (<150) baseline PRU values were excluded.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 22, 2012
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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