High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay

NCT02699008 | Completed DMC

• 1 other identifier: PFT-2015-01
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

High on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss the "true HPR" or over estimate HPR, which may lead to randomized trials failed. It is not known whether combined multiple platelet function testing could assist to ensure"ture"HPR and improve clinical outcomes.

Conditions

Acute Coronary Syndrome

Keywords

clopidogrel；antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  stent thrombosis；ACS；all cause Death；stroke；

  1 year

Secondary Outcomes (1)

• Bleeding events

  1 year

Study Arms (3)

HPR-Ticagrelor row

ACTIVE COMPARATOR

ACS patients aftergoing PCI treated with clopidogrel and aspirin were included. in the 3-5th day after prescription of clopidogrel, platelet function were tested simultaneously by three methods: Light transmittance aggregometry（LTA）, Thrombelastography (TEG) ,Innovance PFA-200 . According to three method results（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR and unHPR, HPR patients were randomized divided into HPR-Ticagrelor(HPR-T) and HPR-Clopidogrel(HPR-C)

Drug: Ticagrelor

HPR-Clopidogrel row

ACTIVE COMPARATOR

Thrombelastography (TEG) ,Innovance PFA-200 . According to three method results（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR and unHPR, HPR patients were randomized divided into HPR-Ticagrelor(HPR-T) and HPR-Clopidogrel(HPR-C)

Drug: Clopidogrel

unHPR row

ACTIVE COMPARATOR

Thrombelastography (TEG) ,Innovance PFA-200 . According to three method results（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR and unHPR, HPR patients were randomized divided into HPR-Ticagrelor(HPR-T) and HPR-Clopidogrel(HPR-C)

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Antiplatelet agent

HPR-Clopidogrel row; unHPR row

Ticagrelor DRUG

New P2Y12 receptor inhibitor antiplatelet agent

HPR-Ticagrelor row

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACS patients（UAP;USTEMI,STEMI）
• Undergoing PCI
• Oral antiplatelet therapy

You may not qualify if:

• Stable CAD

Sponsors & Collaborators

• Wuhan Asia Heart Hospital: lead

Study Sites (1)

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zhou xin, MD

  Wuhan Asia Heart Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: March 4, 2016
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-02

Locations

CN (1)