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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Ticagrelor; Drug: Clopidogrel

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.

• Study Type: Interventional
• Enrollment (Actual): 477
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Stable CAD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HPR-Ticagrelor row; 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; New P2Y12 receptor inhibitor antiplatelet agent
Active Comparator: HPR-Clopidogrel row; 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; Antiplatelet agent
Active Comparator: unHPR row; 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; Antiplatelet agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	stent thrombosis；ACS；all cause Death；stroke；	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events	gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion	1 year

Collaborators and Investigators

• Sponsor: Wuhan Asia Heart Hospital
• Investigators: Study Chair: Zhou xin, MD, Wuhan Asia Heart Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: clopidogrel；antiplatelet therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: PFT-2015-01