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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02699008
Acronym
HOPEmultiPFA
Enrollment
477
Registered
2016-03-04
Start date
2014-01-31
Completion date
2015-10-31
Last updated
2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

clopidogrel;antiplatelet therapy

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 ensuretureHPR 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.

Interventions

DRUGClopidogrel

Antiplatelet agent

DRUGTicagrelor

New P2Y12 receptor inhibitor antiplatelet agent

Sponsors

Wuhan Asia Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Stable CAD

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular events1 yearstent thrombosis;ACS;all cause Death;stroke;

Secondary

MeasureTime frameDescription
Bleeding events1 yeargastrointestinal bleeding;gastrointestinal bleeding;other bleeding need RBC transfusion

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026