NCT01951001

Brief Summary

The purpose of this study is to determine whether the fixed-dose (prasugrel 10 mg/d vs. 5 mg/d) vs. phenotype (platlet function test by VerifyNow P2Y12 assay)-based prasugrel dose adjustment can match therapeutic zone of platelet reactivity in PCI-treated Asians with acute coronary syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 20, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

September 23, 2013

Last Update Submit

August 18, 2020

Conditions

Acute Coronary SyndromePlatelet ThrombusBleeding

Keywords

Acute Coronary Syndrome, Asians, platelet, prasugrel

Outcome Measures

Primary Outcomes (1)

  • Proportion matching to the optimal therapeutic zone

    "Therapeutic zone" has been defined based on the previous clinical trials (85 ≤ VerifyNow P2Y12 Reaction Unit ≤ 208)

    1 month

Secondary Outcomes (3)

  • Prevalence of BARC bleeding

    1 month

  • The cutoff of "LPR" in Asians

    1 month

  • Proportion matching to Asian therapeutic zone of platelet reactivity

    1 month

Other Outcomes (1)

  • Composite of major adverse clinical events (MACE)

    1 month

Study Arms (3)

group 1

ACTIVE COMPARATOR

Fixed-dose Prasugrel of 10 mg/d

Drug: Prasugrel

group 2

ACTIVE COMPARATOR

Fixed-dose Prasugrel of 5 mg/d

Drug: Prasugrel

group 3

ACTIVE COMPARATOR

Phenotype-based prasugrel dose * If patients show PRU \< 85, prasugrel dose will be reduced by 5 mg/d. * If patients show PRU ≥ 85, prasugrel dose will continue 10 mg/d.

Drug: Prasugrel

Interventions

PrasugrelDRUG

For fixed-dose group, patients will receive prasugrel 10 or 5 mg/d for 1 month Irrespective of platelet function test.

group 1group 2group 3

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute coronary syndrome (unstable angina, NSTEMI, and STEMI)
  • Significant coronary artery stenosis (\>50% by visual estimate) eligible for coronary stenting
  • Between 20 and 75 years of age
  • Body weight ≥ 60kg
  • Aspirin dose of 100 mg is recommended
  • Ability to understand and to comply with the study protocol

You may not qualify if:

  • Prior history of ischemic or hemorrhagic stroke or transient ischemic attack, or sub-arachnoids hemorrhage
  • fibrinolytic or abciximab therapy within 48 hours of entry or randomization into the study
  • vitamin K antagonist
  • History of intolerance or allergy to ASA or approved thienopyridines (ticlopidine, clopidogrel, or prasugrel)
  • Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • active pathological bleeding or history of bleeding diathesis
  • Thrombocytopenia (platelets \< 100,000/mm3)
  • Severe hepatic impairment (Child Pugh class C).
  • a condition associated with poor treatment compliance, including dementia or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyeonsang National University Hospital

Jinju, Gyeonsangnam-do,, 660-702, South Korea

Location

Related Publications (1)

  • Jeong YH, Oh JH, Yoon HJ, Park Y, Suh J, Lee SW, Lee K, Kim JS, Chun WJ, Park YH, Nam CW, Kim JH, Ahn JH, Hwang SJ, Hwang JY, Tantry US, Gurbel PA, Shin ES. Pharmacodynamic Profile and Prevalence of Bleeding Episode in East Asian Patients with Acute Coronary Syndromes Treated with Prasugrel Standard-Dose versus De-escalation Strategy: A Randomized A-MATCH Trial. Thromb Haemost. 2021 Oct;121(10):1376-1386. doi: 10.1055/a-1346-3300. Epub 2021 Mar 3.

    PMID: 33401330DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeHemorrhage

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Young-Hoon Jeong, MD, PhD

    Gyeongsang National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 26, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

October 1, 2018

Last Updated

August 20, 2020

Record last verified: 2020-07

Locations

KR(1)