Efficacy and Safety of Low-dose Ticagrelor

NCT03381742 | Completed Phase 2 Results DMC

• 1 other identifier: ACS-2
• Study Type: interventional
• Target: 3,043
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• ADP-induced Inhibition of Platelet Aggregation

  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, 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 inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition.

  up to 5 days

• Number of Participants With Bleeding (Major or Minor Bleeding)

  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.)

  up to 5 days

Secondary Outcomes (4)

• ADP-induced Platelet-fibrin Clot Strength (MA)

  up to 5 days

• Number of Participants With High On-Treatment Platelet Reactivity (HTPR)

  up to 5 days

• Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke)

  up to 5 days

• Number of Participants With New-onset Dyspnea

  up to 5 days

Study Arms (4)

ticagrelor 45mg bidpo.

EXPERIMENTAL

To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.

Drug: Ticagrelor

ticagrelor 90mg qdpo.

EXPERIMENTAL

To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.

Drug: ticagrelor

ticagrelor 90mg bidpo.

ACTIVE COMPARATOR

To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.

Drug: ticagrelor

clopidogrel 75mg qdpo.

ACTIVE COMPARATOR

To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.

Drug: clopidogrel

Interventions

ticagrelor DRUG

ticagrelor 45 mg twice daily for 5 consecutive days at least.

ticagrelor 45mg bidpo.

clopidogrel DRUG

clopidogrel 75 mg once daily for 5 consecutive days at least.

clopidogrel 75mg qdpo.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary artery disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead
• Beijing Anzhen Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Central Hospital of Jia Mu Si City: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• RenJi Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Weifang People's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Shengjing Hospital: collaborator
• Shaanxi Provincial People's Hospital: collaborator

Study Sites (1)

Thromboela-Stogram

Beijing, 100001, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Yue Li
• Organization: Department of Cardiology, the First Affiliated Hospital, Harbin Medical University, Harbin, China

ly99ly@vip.163.com

86-451-85555673

Study Officials

• Yue Li, MD

  Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 22, 2017
• Study Start: December 13, 2017
• Primary Completion: December 13, 2018
• Study Completion: February 13, 2019
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-06

Locations

CN (1)