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Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01603082
First received: May 18, 2012
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Condition Intervention Phase
Acute Coronary Syndrome
Drug: Ticagrelor
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Participants with low (<150) baseline PRU values were excluded.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Participants with low (<150) baseline PRU values were excluded.


Enrollment: 343
Study Start Date: July 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor - 180 mg loading dose
Drug: Ticagrelor
180 mg loading dose
Active Comparator: Clopidogrel
Clopidogrel - 600 mg loading dose
Drug: Clopidogrel
600 mg loading dose

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)
  Eligibility

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603082

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Francisco, California, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
United States, Michigan
Research Site
Ypsilanti, Michigan, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Mississippi
Research Site
Tupelo, Mississippi, United States
United States, Missouri
Research Site
North Kansas, Missouri, United States
United States, New Jersey
Research Site
Belleville, New Jersey, United States
United States, New York
Research Site
Bronx, New York, United States
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Greensboro, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Texas
Research Site
Tyler, Texas, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Glenn F. Carlson, MD AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01603082     History of Changes
Other Study ID Numbers: D5130L00014 
Study First Received: May 18, 2012
Results First Received: June 1, 2015
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Clopidogrel
Ticlopidine
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016