Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

This study is currently recruiting participants.
Verified January 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01603082
First received: May 18, 2012
Last updated: January 22, 2014
Last verified: January 2014
  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 measured by Platelet Reactivity Unit [ Time Frame: At 2 hours after the loading dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 0.5, end of PCI, and 8 hours after the loading dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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 and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603082

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com

  Show 33 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Juan Maya, MD AstraZeneca Pharmaceuticals Room C3C-023 PO Box 15437 Wilmington, DE 19850-5437 USA
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01603082     History of Changes
Other Study ID Numbers: D5130L00014
Study First Received: May 18, 2012
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014