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Fixed-dose vs. Phenotype-based PrAsugrel Dose to MATCH Therapeutic Zone in Asians With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT01951001
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Gyeongsang National University Hospital

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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Platelet Thrombus Bleeding Drug: Prasugrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fixed-dose vs. Phenotype-based PrAsugrel Dose to MATCH Therapeutic Zone in Asians With Acute Coronary Syndrome
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel

Arm Intervention/treatment
Active Comparator: group 1
Fixed-dose Prasugrel of 10 mg/d
Drug: Prasugrel
For fixed-dose group, patients will receive prasugrel 10 or 5 mg/d for 1 month Irrespective of platelet function test.

Active Comparator: group 2
Fixed-dose Prasugrel of 5 mg/d
Drug: Prasugrel
For fixed-dose group, patients will receive prasugrel 10 or 5 mg/d for 1 month Irrespective of platelet function test.

Active Comparator: group 3

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




Primary Outcome Measures :
  1. Proportion matching to the optimal therapeutic zone [ Time Frame: 1 month ]
    "Therapeutic zone" has been defined based on the previous clinical trials (85 ≤ VerifyNow P2Y12 Reaction Unit ≤ 208)


Secondary Outcome Measures :
  1. Prevalence of BARC bleeding [ Time Frame: 1 month ]

    BARC Definition for bleeding: defined as type 1, 2, 3 (3a, 3b and 3c), and 5 (5a and 5b), according to the Bleeding Academic Research Consortium classification

    • Type 1 (nuisance or superficial bleeding
    • Type 2 (internal bleeding)
    • Type 3a (TIMI minor bleeding)
    • Type 3b (TIMI major bleeding)
    • Type 3c (life threatening bleeding)
    • Type 4 (CABG-related bleeding)
    • Type 5a (probable fatal bleeding)
    • Type 5b (definite fatal bleeding)

  2. The cutoff of "LPR" in Asians [ Time Frame: 1 month ]
    "LPR" means "low on-treatment platelet reactivity", which can increase the risk of clinically serious bleeding

  3. Proportion matching to Asian therapeutic zone of platelet reactivity [ Time Frame: 1 month ]

    Multiple clinical studies have shown that the cutoff of about 266 PRU is associated with the risk of ischemic event in Asians.

    LPR will be based on the data of the A-MATCh trial.



Other Outcome Measures:
  1. Composite of major adverse clinical events (MACE) [ Time Frame: 1 month ]
    MACE includes composite of CV death, non-fatal MI, stent thrombosis, stroke or ischemia-driven TVR



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951001


Locations
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Korea, Republic of
Gyeonsang National University Hospital
Jinju, Gyeonsangnam-do,, Korea, Republic of, 660-702
Sponsors and Collaborators
Gyeongsang National University Hospital
Investigators
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Principal Investigator: Young-Hoon Jeong, MD, PhD Gyeongsang National University Hospital
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Responsible Party: Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT01951001    
Other Study ID Numbers: A-MATCH
2013-05-002-004 ( Other Identifier: GNUH IRB )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: July 2020
Keywords provided by Gyeongsang National University Hospital:
Acute Coronary Syndrome, Asians, platelet, prasugrel
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors