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

May 18, 2012
January 22, 2014
July 2012
October 2014   (final data collection date for primary outcome measure)
Inhibition of the P2Y12 receptor measured by Platelet Reactivity Unit [ Time Frame: At 2 hours after the loading dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01603082 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
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

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

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)

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Ticagrelor
    180 mg loading dose
  • Drug: Clopidogrel
    600 mg loading dose
  • Experimental: Ticagrelor
    Ticagrelor - 180 mg loading dose
    Intervention: Drug: Ticagrelor
  • Active Comparator: Clopidogrel
    Clopidogrel - 600 mg loading dose
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
United States
 
NCT01603082
D5130L00014
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Juan Maya, MD AstraZeneca Pharmaceuticals Room C3C-023 PO Box 15437 Wilmington, DE 19850-5437 USA
AstraZeneca
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP