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PROTECT-TIMI 30 Trial

M

Millennium Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Unstable Angina

Treatments

Procedure: Percutaneous Coronary Intervention (PCI)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.

Full description

Platelet inhibitor drugs

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:

    • diabetes
    • elevated cardiac proteins in the blood (indicating acute coronary syndrome)
  • Be willing and able to give informed consent

Exclusion criteria

  • uncontrolled hypertension
  • cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
  • prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
  • any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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