問卷

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberP04736
NCT Number(ClinicalTrials.gov Identfier)NCT00527943

2009-01-01 - 2013-12-31

Phase III

Terminated13

ICD-10I24.9

Acute ischemic heart disease, unspecified

ICD-9411.89

Other acute and subacute forms of ischemic heart disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Min-Ji Charng Division of Cardiovascular Diseases

Co-Principal Investigator

  • 李文興 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases

Co-Principal Investigator

  • 陳俊吉 Division of Cardiovascular Diseases
  • 李振宏 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳炯仁 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator

Co-Principal Investigator

  • 張盛雄 Division of Cardiovascular Diseases
  • 劉俊傑 Division of Cardiovascular Diseases
  • 蘇正煌 Division of Cardiovascular Diseases
  • 李應湘 Division of Cardiovascular Diseases
  • 藍偉仁 Division of Cardiovascular Diseases
  • 蔡政廷 Division of Cardiovascular Diseases
  • 洪大川 Division of Cardiovascular Diseases
  • 陳俊延 Division of Cardiovascular Diseases
  • Ping-Ing Lee Division of Cardiovascular Diseases
  • 侯嘉殷 Division of Cardiovascular Diseases
  • 林柏霖 Division of Cardiovascular Diseases
  • 蔡瑞鵬 Division of Cardiovascular Diseases
  • 吳懿哲 Division of Cardiovascular Diseases
  • 顏志軒 Division of Cardiovascular Diseases
  • 陳正熙 Division of Cardiovascular Diseases
  • 彭明正 Division of Cardiovascular Diseases
  • 郭任遠 Division of Cardiovascular Diseases
  • 林慧君 Division of Cardiovascular Diseases
  • Hung-I Yeh Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Hsien Li Kao Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 翁國昌 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 蔡青峰 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 徐國基 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 林申昌 Division of Cardiovascular Diseases
  • 洪惠風 Division of Cardiovascular Diseases
  • 邱俊仁 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Zhih-Cherng Chen Division of General Internal Medicine

Co-Principal Investigator

  • 吳文憲 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 殷偉賢 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 王鑑忠 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蔡正道 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 陳雅珮 Division of General Internal Medicine
  • 夏建勳 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator WEN-TER Lai Division of Cardiovascular Diseases

Co-Principal Investigator

Principal Investigator

Co-Principal Investigator

  • 彭明正 Division of Cardiovascular Diseases
  • Hung-I Yeh Division of Cardiovascular Diseases
  • 顏志軒 Division of Cardiovascular Diseases
  • 李應湘 Division of Cardiovascular Diseases
  • 林柏霖 Division of Cardiovascular Diseases
  • 劉俊傑 Division of Cardiovascular Diseases
  • 郭任遠 Division of Cardiovascular Diseases
  • 陳俊延 Division of Cardiovascular Diseases
  • 侯嘉殷 Division of Cardiovascular Diseases
  • Ping-Ing Lee Division of Cardiovascular Diseases
  • 洪大川 Division of Cardiovascular Diseases
  • 吳懿哲 Division of Cardiovascular Diseases
  • 蔡政廷 Division of Cardiovascular Diseases
  • 蔡瑞鵬 Division of Cardiovascular Diseases
  • 蘇正煌 Division of Cardiovascular Diseases
  • 林慧君 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Acute Coronary Symdrome

Objectives

The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

Test Drug

SCH530348

Active Ingredient

SCH 530348 bisulfate

Dosage Form

tablet

Dosage

40mg or 2.5mg

Endpoints

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization

Inclution Criteria

Men and women at least 18 years old with current clinical manifestation of non-ST-segment-elevation myocardial infarction (heart attack) according to the following three criteria:

current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heart attack)
AND

either of the following:

concurrent elevation of troponin I or T, or of creatine kinase - myocardial band (CK-MB) to a level above the upper limit of normal, OR
concurrent appropriate electrocardiographic evidence
AND

any one (or more) of the following:

age >= 55 years
documented history of prior heart attack or coronary revascularization (eg, angioplasty [PCI], coronary artery replacement [CABG])
diabetes (documented use of insulin or oral hypoglycemic[s])
documented history of peripheral arterial disease

Exclusion Criteria

history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor, or aneurysm
any bleeding disorder or abnormality
sustained severe hypertension or valvular heart disease
current or recent platelet count <100,000 mm^3
planned or ongoing treatment with a blood thinning medication
pregnancy
any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study

The Estimated Number of Participants

  • Taiwan

    300 participants

  • Global

    participants