Ticagrelor and Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With CHD

NCT03614832 | Unknown Phase 4 DMC

• 1 other identifier: CHD-201802
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study sought to observe the effects of optimal dose of ticagrelor（90 mg qd）ticagrelor and double standard-dose clopidogrel on platelet reactivity in coronary heart disease patients with high on-treatment platelet reactivity (HTPR) while on clopidogrel. HTPR with clopidogrel administration in coronary heart disease (CHD) patients has associated with an increased risk of adverse events. Newer P2Y12 inhibitors ticagrelor (90mg BID) provide stronger platelet inhibition compared with clopidogrel, but a low-dose of ticagrelor (90mg QD) has not been previously studied in Chinese CHD patients with HTPR.

Conditions

Platelet Reactivity

Keywords

ticagrelor; clopidogrel; platelet reactivity

Outcome Measures

Primary Outcomes (1)

• The plateletinhibition ratio.

  Thromboelastography (TEG) was used to measure platelet inhibition ratio.

  up to 7 days

Secondary Outcomes (1)

• The platelet aggregation ratio.

  up to 7 days

Study Arms (2)

Ticagrelor 90 mg

EXPERIMENTAL

To observe low-dose of ticagrelor（90 mg once daily oral）on platelet aggregation in clopidogrel resistance's patients with coronary heart disease.

Drug: Ticagrelor 90 mg

Clopidogrel 150 mg

ACTIVE COMPARATOR

To observe double standard-dose clopidogrel （150 mg once daily oral）on platelet aggregation in clopidogrel resistance's patients with coronary heart disease.

Drug: Clopidogrel 150 mg

Interventions

Ticagrelor 90 mg DRUG

half-dose ticagrelor treatment (90 mg loading dose, then 90 mg once daily) for 1 week.

Ticagrelor 90 mg

Clopidogrel 150 mg DRUG

double standard-dose clopidogrel treatment (150 mg loading dose, then 150 mg once daily) for 1 week.

Clopidogrel 150 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary heart disease (CHD) ;
• Patients with high on-treatment platelet reactivity (HTPR) while on clopidogrel. Meet the one standards of the following:
• (1) The platelet aggregation rate (PAgR) measured with light transmission aggregometry (LTA) is decreased no more than 10% from baseline level, or PAgR is more than 46%; (2) The percentage of inhibition of ADP-induced platelet aggregation measured by thrombelastogram is not more than 30%; (3) The PRU of inhibition of ADP-induced platelet aggregation measured by VerifyNow \>208.

You may not qualify if:

• Severe lung injury; 2.Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period; 3.Platelet count \<100g/L; 4.Creatinine clearance rate \< 30ml/min; 5.Severe liver injury. 6.Diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction \< 40%); 7.A history of bleeding tendency; 8.Aspirin, ticagrelor or clopidogrel allergies;

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

the first affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

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

Study Officials

• Yue Li, PhD

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangzhong Liu, PhD

CONTACT

86-451-85555672; lgz2700@126.com

Yue Li, PhD

CONTACT

86-451-85555673; ly99ly@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 3, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 3, 2018

Record last verified: 2018-02

Locations

CN (1)