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High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay (HOPEmultiPFA)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Clopidogrel
Ticagrelor
Sponsored by
Wuhan Asia Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring clopidogrel；antiplatelet therapy

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Stable CAD

Sites / Locations

  • Wuhan Asia Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

HPR-Ticagrelor row

HPR-Clopidogrel row

unHPR row

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Major adverse cardiovascular events
stent thrombosis；ACS；all cause Death；stroke；

Secondary Outcome Measures

Bleeding events
gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion

Full Information

First Posted
October 30, 2015
Last Updated
February 29, 2016
Sponsor
Wuhan Asia Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02699008
Brief Title
High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Asia Heart Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
clopidogrel；antiplatelet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPR-Ticagrelor row
Arm Type
Active Comparator
Arm Description
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)
Arm Title
HPR-Clopidogrel row
Arm Type
Active Comparator
Arm Description
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)
Arm Title
unHPR row
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Antiplatelet agent
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
New P2Y12 receptor inhibitor antiplatelet agent
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events
Description
stent thrombosis；ACS；all cause Death；stroke；
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bleeding events
Description
gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ACS patients（UAP;USTEMI,STEMI） Undergoing PCI Oral antiplatelet therapy Exclusion Criteria: Stable CAD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou xin, MD
Organizational Affiliation
Wuhan Asia Heart Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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