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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Gyeongsang National University Hospital
Sponsor:
Information provided by (Responsible Party):
Gyeongsang National University Hospital
ClinicalTrials.gov Identifier:
NCT01951001
First received: September 23, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Platelet Thrombus
Bleeding
Drug: Prasugrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fixed-dose vs. Phenotype-based PrAsugrel Dose to MATCH Therapeutic Zone in Asians With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Gyeongsang National University Hospital:

Primary Outcome Measures:
  • Percentage of patients showing the optimal therapeutic zone [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    "Therapeutic zone" has been defined based on the previous clinical trials (95 ≤ VerifyNow P2Y12 Reaction Unit ≤ 208)


Secondary Outcome Measures:
  • Prevalence of BARC bleeding (type 2 + 3 + 5 or type 1+ 2 + 3 + 4+ 5) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    BARC Definition for bleeding: defined as type 1, 2, 3 (3a, 3b and 3c), 4, 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)

  • The cutoff of "LPR" in Asians [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    "LPR" means "low on-treatment platelet reactivity", which can increase the risk of clinically serious bleeding

  • Percentage of patietns to match Asian therapeutic zone of platelet reactivity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    Multiple clinical studies have shown that the cutoff of about 275 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:
  • Composite of major adverse clinical events (MACE) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    MACE includes composite of CV death, non-fatal MI, stent thrombosis, stroke or ischemia-driven TVR


Estimated Enrollment: 240
Study Start Date: July 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ≤ 94, prasugrel dose will be reduced by 5 mg/d.
  • If patients show PRU > 94, 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951001

Contacts
Contact: Young-Hoon Jeong, MD, PhD 82 10 7343 4670 goodoctor@naver.com
Contact: Eun-Sook Kim, Coordinator 82 55 750 9078 ulim212@hanmail.net

Locations
Korea, Republic of
Gyeonsang National University Hospital Recruiting
Jinju, Gyeonsangnam-do,, Korea, Republic of, 660-702
Contact: Young-Hoon Jeong, MD, PhD    82 10 7343 4670    goodoctor@naver.com   
Principal Investigator: Young-Hoon Jeong, MD, PhD         
Sponsors and Collaborators
Gyeongsang National University Hospital
Investigators
Principal Investigator: Young-Hoon Jeong, MD, PhD Gyeongsang National University Hospital
  More Information

No publications provided

Responsible Party: Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT01951001     History of Changes
Other Study ID Numbers: A-MATCH, 2013-05-002-004
Study First Received: September 23, 2013
Last Updated: April 30, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Gyeongsang National University Hospital:
Acute Coronary Syndrome, Asians, platelet, prasugrel

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Prasugrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014