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

Acute Coronary Syndrome Clinical Trial

— HOPEmultiPFA  

Official title:

High On-treatment Platelet Reactivity to Adenosine Diphosphate Identified by Multiple Platelet Function Assay Guide to Modify Anti-platelet Strategy in Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699008
• Other study ID #: PFT-2015-01
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: February 29, 2016
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Wuhan Asia Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This was a single-center, randomized, prospective study. ACS patients undergoing 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: MPAADP by Light transmittance aggregometry（LTA）, MAADP by Thrombelastography (TEG) ,and CTP2Y by Innovance PFA-200 . According to three result（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(n=125) or unHPR(n=232), HPR patients were divided into HPR-Ticagrelor(HPR-T)and HPR-Clopidogrel(HPR-C) randomized. HPR-T group(n=77) patients' antiplatelet agents changed to ticagrelor, both unHPR and HPR-C groups keep unchanged(Clopidogrel). The major adverse cardiovascular events (MACE) were recorded during 1 year Follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• ACS patients(UAP;USTEMI,STEMI)

• Undergoing PCI

• Oral antiplatelet therapy

Exclusion Criteria:

• Stable CAD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• Clopidogrel
Antiplatelet agent
• Ticagrelor
New P2Y12 receptor inhibitor antiplatelet agent

Locations

Country	Name	City	State
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	stent thrombosis;ACS;all cause Death;stroke;	1 year	Yes
Secondary	Bleeding events	gastrointestinal bleeding;gastrointestinal bleeding;other bleeding need RBC transfusion	1 year	Yes