Phase 4 N=100 Randomized Treatment

Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

Acute Coronary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01603082 ↗

Enrolled (actual)

100

Serious AEs

14.0%

Results posted

Dec 2015

Primary outcome: 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™ — 98.4; 257.5 PRU — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ticagrelor (Drug); Clopidogrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
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™	98.4; 257.5	<0.001 sig
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™	277.3; 297.7; 43.8; 202.3; 264.2; 307.8	0.182

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01603082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.