Phase 4
Completed N=278
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
Non ST Segment Elevation Acute Coronary Syndrome
Source: ClinicalTrials.gov NCT01962428 ↗
Enrolled (actual)
278
Serious AEs
2.9%
Results posted
Nov 2016
Primary outcomePrimary: Platelet Reactivity Index(PRI) Measured by VASP-P — 16.7; 12.2 percentage of 100
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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.
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. Informational only — not medical advice.