Clinical Trial: Early Invasive Versus Conservative Therapy in Women With an Acute Coronary Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early Invasive Versus Conservative Therapy in Women With an Acute Coronary Syndrome

Brief Summary: The aim of this research is to evaluate the effect of early invasive therapy and appropriate revascularization compared with conservative management and selective revascularization among women with an acute coronary syndrome.

Detailed Summary:

This study aims to enroll 1,000 women who present with AcuteCoronarySyndorme ( ACS). Patients will be identified through screening of all women admitted for chest pain, and those women with positive cardiac enzymes after operative procedures. After receiving permission to approach the potential subjects, trained and delegated study personnel will present the study to the patient. The informed consent process will be completed by the study coordinator, PI or co-investigator. The patient will have all procedures, risks and benefits explained and offered time to read and review the informed consent form. They will be given adequate time to ask questions, consult with family members or primary physicians. Specifically, written informed consent will be obtained in the emergency department or in the cardiology ward/unit before the patient is sedated/in the catheterization laboratory. . When a patient consents to participate in the study, their treatment assignment will be randomly determined by opening a sealed envelope that contains one of two treatment strategies. The blinding envelopes will be created by the Biostatistics group and will be sealed.

Once informed written consent is obtained (see accompanying flow chart), each patient will be randomly assigned to early invasive therapy versus conservative management. All patients will be administered aspirin 325 mg, clopidogrel 600 mg, and atorvastatin 80 mg. Anti-thrombin therapy (unfractionated heparin or bivalirudin according to physician discretion) will be administered intravenously. If anti-thrombin therapy was administered prior to randomization, this agent will be continued through catheterization and titrated if necessary to achieve desired effect.

Patients assigned to an early invasive strategy will undergo coronary angiography within 48 hours and have percutaneous cor
Sponsor: University of Florida

Current Primary Outcome:

  • cumulative incidence of death [ Time Frame: 1 year ]
    among women with an acute coronary syndrome between the 2 randomized treatment groups
  • cumulative incidence of myocardial infarction [ Time Frame: 1 year ]
    among women with an acute coronary syndrome between the 2 randomized treatment groups
  • cumulative incidence of rehospitalization for ACS [ Time Frame: 1 year ]
    among women with an acute coronary syndrome between the 2 randomized treatment groups
  • cumulative incidence of stroke [ Time Frame: 1 year ]
    among women with an acute coronary syndrome between the 2 randomized treatment groups
  • cumulative incidence of major bleeding [ Time Frame: 1 year ]
    among women with an acute coronary syndrome between the 2 randomized treatment groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Death [ Time Frame: 6months, 1 year, 2 year ]
    Composite ischemic outcome
  • Myocardial Infarction [ Time Frame: 6 months, 1 year, 2 year ]
    Composite ischemic outcome
  • Rehospitalization for ACS [ Time Frame: 6 months, 1 year, 2 year ]
    Composite ischemic outcome
  • Stroke [ Time Frame: 6 months, 1 year, 2 year ]
    Composite ischemic outcome
  • major bleeding [ Time Frame: 6 months, 1 year, 2 year ]
    Composite ischemic outcome
  • Death [ Time Frame: 6 months, 1 year, 2 year ]
    Individual components
  • Myocardial Infarction [ Time Frame: 6 months, 1 year, 2 year ]
    Individual components
  • Stroke [ Time Frame: 6 months, 1 year, 2year ]
    Individual components
  • Rehospitalization for ACS [ Time Frame: 6 months, 1 year, 2 year ]
    Individual components
  • major bleeding [ Time Frame: 6 months, 1 year, 2 year ]
    Individual components


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: January 23, 2015
Date Started: April 2009
Date Completion:
Last Updated: February 12, 2015
Last Verified: February 2015