Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603082
• Other study ID #: D5130L00014
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2012
• Last updated: November 9, 2015
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 130 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor
180 mg loading dose
• Clopidogrel
600 mg loading dose

Locations

Country	Name	City	State
United States	Research Site	Belleville	New Jersey
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bronx	New York
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Jacksonville	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	New York	New York
United States	Research Site	North Kansas	Missouri
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Richmond	Virginia
United States	Research Site	San Francisco	California
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Tyler	Texas
United States	Research Site	Washington	District of Columbia
United States	Research Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No