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Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atherosclerosis; Myocardial Ischemia; Myocardial Infarction

Intervention: Vorapaxar (Drug); Placebo (Drug); Aspirin (Drug); Clopidogrel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.

Clinical Details

Official title: Phase II Study of SCH 530348 in Subjects With Acute Coronary Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)

Secondary outcome:

Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI

Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI

Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit

Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit

Mean CD40 Ligand Levels Among Participants Who Underwent PCI

Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI

Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge

Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI

Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI

Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events

Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion

Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization

Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI

Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI

Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events

Detailed description: The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women aged 18 years or more with history of cardiac ischemia related chest

discomfort of > 10 minutes duration < 24 hours prior to randomization, and having at least 1 of the following A or B. Participants who are planned to undergo PCI will be the target participants.

- A: Positive biomarkers [Elevated troponin I or creatinine kinase MB isozyme

greater than the site's upper limit of normal (ULN)] at or before registration

- B: Electrocardiogram (ECG) changes: ST segment depression >= 0. 1 mV (>=1 mm),

or transient (<30 minutes) ST segment elevation >= 0. 1 mV (>=1 mm) in at least 2 contiguous leads

- Willing to give appropriate informed consent and complete all study-related

procedures, and able to adhere to dosing and all visit schedules.

- Women of child-bearing potential (all postmenarchal women who are <1 years menopausal

or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication. Exclusion Criteria:

- Pregnant and nursing mothers (premenopausal women should have a negative pregnancy

test result confirmed before enrollment)

- Any serious illness or any condition that the investigator feels would pose a

significant hazard to the participant if investigational therapy were initiated

- known hypersensitivity to any component of the current investigational product;

- Participation in a study of experimental therapy or use of any investigational drug

within 30 days before enrollment

- Member of the staff personnel directly involved with this study;

- Family member of the investigational study staff;

- History of a bleeding diathesis, or evidence of active abnormal bleeding within 30

days before enrollment

- History of a hemorrhagic stroke at any time

- Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure

>110 mm Hg) while receiving therapy;

- Major surgery within 2 weeks prior to enrollment

- Known platelet count <100,000/mm^3

- Uncontrolled cardiac arrhythmia;

- Known impairment of renal function (serum creatinine >2. 0 mg/dL [>176. 8 umol/L]),

dysproteinemia, nephrotic syndrome, or other renal disease;

- Active or chronic hepatobiliary or hepatic disease, or aspartate aminotransferase

(AST) or alanine aminotransferase (ALT) activity more than two times greater than the upper limit of the laboratory reference range

- Anticipated staged PCI

- Concurrent or anticipated treatment with warfarin, factor Xa inhibitor, direct

thrombin inhibitor, or antiplatelet agents except aspirin and ticlopidine after enrollment

- Anticipated intracoronary brachytherapy

Locations and Contacts

Additional Information

Starting date: December 2006
Last updated: July 20, 2015

Page last updated: August 23, 2015

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