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NCT03381742

Efficacy and Safety of Low-dose Ticagrelor

Completed Phase 2, PHASE3 Results posted Last updated 30 September 2019
What this trial tests

Phase 2, PHASE3 trial testing Ticagrelor in Coronary Artery Disease in 3,043 participants. Completed in 13 February 2019.

Timeline
13 December 2017
Primary endpoint
13 December 2018
13 February 2019

Quick facts

Lead sponsorFirst Affiliated Hospital of Harbin Medical University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment3,043
Start date13 December 2017
Primary completion13 December 2018
Estimated completion13 February 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital of Harbin Medical University

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

ADP-induced Inhibition of Platelet Aggregation Primary · up to 5 days

The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Le

GroupValue95% CI
Clopidogrel 75mg Qdpo.54.931.9 – 79.1
Ticagrelor 90mg Bidpo.80.664.1 – 94
Ticagrelor 45mg Bidpo.73.652.6 – 93.7
Ticagrelor 90mg Qdpo.6646.9 – 87
Number of Participants With Bleeding (Major or Minor Bleeding) Primary · up to 5 days

Major bleeding was defined as type ≥ 3 and minor bleeding as types 1 and 2, in accordance to the Bleeding Academic Research Consortium classification. (Mehran R et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.)

GroupValue95% CI
Clopidogrel 75mg Qdpo.15
Ticagrelor 90mg Bidpo.30
Ticagrelor 45mg Bidpo.14
Ticagrelor 90mg Qdpo.9
Clopidogrel 75mg Qdpo.0
Ticagrelor 90mg Bidpo.0
Ticagrelor 45mg Bidpo.0
Ticagrelor 90mg Qdpo.0
Clopidogrel 75mg Qdpo.1496
Ticagrelor 90mg Bidpo.471
Ticagrelor 45mg Bidpo.511
Ticagrelor 90mg Qdpo.497
ADP-induced Platelet-fibrin Clot Strength (MA) Secondary · up to 5 days

The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA\>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA\<31

GroupValue95% CI
Clopidogrel 75mg Qdpo.40.327 – 51.6
Ticagrelor 90mg Bidpo.28.418.5 – 38.9
Ticagrelor 45mg Bidpo.32.319.5 – 43.9
Ticagrelor 90mg Qdpo.34.0523.6 – 46.1
Number of Participants With High On-Treatment Platelet Reactivity (HTPR) Secondary · up to 5 days

HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm.

GroupValue95% CI
Clopidogrel 75mg Qdpo.317
Ticagrelor 90mg Bidpo.13
Ticagrelor 45mg Bidpo.23
Ticagrelor 90mg Qdpo.32
Clopidogrel 75mg Qdpo.1194
Ticagrelor 90mg Bidpo.488
Ticagrelor 45mg Bidpo.502
Ticagrelor 90mg Qdpo.474
Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke) Secondary · up to 5 days

Cardiovascular death was defined as sudden cardiac death, fatal myocardial infarction, death due to heart failure, or death due to other cardiovascular causes. Stroke was defined as the focal loss of neurologic function caused by an ischemic or a hemorrhagic event with residual symptoms lasting at least 24 hours or eventually leading to death.

GroupValue95% CI
Clopidogrel 75mg Qdpo.0
Ticagrelor 90mg Bidpo.0
Ticagrelor 45mg Bidpo.0
Ticagrelor 90mg Qdpo.0
Clopidogrel 75mg Qdpo.1511
Ticagrelor 90mg Bidpo.501
Ticagrelor 45mg Bidpo.525
Ticagrelor 90mg Qdpo.506
Clopidogrel 75mg Qdpo.0
Ticagrelor 90mg Bidpo.0
Ticagrelor 45mg Bidpo.0
Ticagrelor 90mg Qdpo.0
Clopidogrel 75mg Qdpo.0
Ticagrelor 90mg Bidpo.0
Ticagrelor 45mg Bidpo.0
Ticagrelor 90mg Qdpo.0
Number of Participants With New-onset Dyspnea Secondary · up to 5 days

New-onset dyspnea in patients without previous history of dyspnea

GroupValue95% CI
Clopidogrel 75mg Qdpo.34
Ticagrelor 90mg Bidpo.29
Ticagrelor 45mg Bidpo.32
Ticagrelor 90mg Qdpo.28
Clopidogrel 75mg Qdpo.1477
Ticagrelor 90mg Bidpo.472
Ticagrelor 45mg Bidpo.493
Ticagrelor 90mg Qdpo.478

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and safety of different ticagrelor regimens versus clopidogrel in patients with coronary artery disease: a retrospective multicenter study (SUPERIOR).
    Shi J, He M, Wang W, Liu G, et al · · 2021 · cited 6× · PMID 32090650 · DOI 10.1080/09537104.2020.1732328

Verify or expand the search:

Other trials of Ticagrelor

Trials testing the same drug.

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other First Affiliated Hospital of Harbin Medical University trials

Trials by the same sponsor.

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