Phase 4 N=278 Randomized Treatment

Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

Non ST Segment Elevation Acute Coronary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01962428 ↗

Enrolled (actual)

278

Serious AEs

2.9%

Results posted

Nov 2016

Primary outcome: Primary: Platelet Reactivity Index(PRI) Measured by VASP-P — 16.7; 12.2 percentage of 100

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ticagrelor (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: General Hospital of Chinese Armed Police Forces
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Platelet Reactivity Index(PRI) Measured by VASP-P	16.7; 12.2	—
SECONDARY Platelet Reactivity Index (PRI) Measured by VASP-P	—	—
SECONDARY Bleeding Events	—	—

Summary

It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.

Eligibility Criteria

Inclusion Criteria

Provision of informed consent prior to any study specific procedures.
Male or non-pregnant female; aged from 18 to 80 years old.
Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI.

Exclusion Criteria

Any contraindication against the use of ticagrelor.
On treatment with a P2Y12 receptor antagonist in past 30 days.
Known allergies to aspirin or ticagrelor.
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Known blood dyscrasia or bleeding diathesis.
ST-segment elevation acute myocardial infarction.
Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography.
Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01962428). 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.