Phase 3
Completed N=3,043
Efficacy and Safety of Low-dose Ticagrelor
Source: ClinicalTrials.gov NCT03381742 ↗Enrolled (actual)
3,043
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: ADP-induced Inhibition of Platelet Aggregation — 54.9; 80.6; 73.6; 66 percentage of inhibition of platelet agg
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADP-induced Inhibition of Platelet Aggregation |
54.9; 80.6; 73.6; 66 | — |
| PRIMARY Number of Participants With Bleeding (Major or Minor Bleeding) |
15; 30; 14; 9; 0; 0 | — |
| SECONDARY ADP-induced Platelet-fibrin Clot Strength (MA) |
40.3; 28.4; 32.3; 34.05 | — |
| SECONDARY Number of Participants With High On-Treatment Platelet Reactivity (HTPR) |
317; 13; 23; 32; 1194; 488 | — |
| SECONDARY Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke) |
0; 0; 0; 0; 1511; 501 | — |
| SECONDARY Number of Participants With New-onset Dyspnea |
34; 29; 32; 28; 1477; 472 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with coronary artery disease
Exclusion Criteria
- younger than 18 years of age;
- anti-platelet therapy with clopidogrel or ticagrelor for less than 5 days;
- previous or current treatment with any other potentially confounding drugs.
Data sourced from ClinicalTrials.gov (NCT03381742). 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.