NCT02357212

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

4.4 years

First QC Date

January 23, 2015

Last Update Submit

February 12, 2015

Conditions

Acute Coronary Syndrome

Keywords

Non-St elevation acute coronary syndrome

Outcome Measures

Primary Outcomes (5)

  • cumulative incidence of death

    among women with an acute coronary syndrome between the 2 randomized treatment groups

    1 year

  • cumulative incidence of myocardial infarction

    among women with an acute coronary syndrome between the 2 randomized treatment groups

    1 year

  • cumulative incidence of rehospitalization for ACS

    among women with an acute coronary syndrome between the 2 randomized treatment groups

    1 year

  • cumulative incidence of stroke

    among women with an acute coronary syndrome between the 2 randomized treatment groups

    1 year

  • cumulative incidence of major bleeding

    among women with an acute coronary syndrome between the 2 randomized treatment groups

    1 year

Secondary Outcomes (10)

  • Death

    6months, 1 year, 2 year

  • Myocardial Infarction

    6 months, 1 year, 2 year

  • Rehospitalization for ACS

    6 months, 1 year, 2 year

  • Stroke

    6 months, 1 year, 2 year

  • major bleeding

    6 months, 1 year, 2 year

  • +5 more secondary outcomes

Other Outcomes (1)

  • Urgent need for revascularization

    1 year

Study Arms (2)

Early Invasive

OTHER

Patients assigned to an early invasive strategy will undergo coronary angiography within 48 hours and have percutaneous coronary intervention or coronary artery bypass grafting performed as soon as possible during the initial hospitalization if deemed appropriate.

Procedure: coronary angiography

Conservative management

OTHER

Patients assigned to conservative management will be treated with anti-anginal medications, aspirin, clopidogrel, atorvastatin, and other guideline recommended medicines. Patients will have an echocardiogram and adenosine stress testing

Procedure: adenosine stress test

Interventions

coronary angiographyPROCEDURE

invasive procedure performed to determine coronary anatomy

Early Invasive
adenosine stress testPROCEDURE

non-invasive procedure to determine area of cardiac ischemia

Also known as: stress test
Conservative management

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 18 years or older
  • Non-ST-elevation acute coronary syndrome (defined as new onset chest discomfort that occurs at rest or with low levels of activity/or emotion within the preceding 48 hours) with either:
  • elevated troponin T (≥ 0.03 ng per milliliter),
  • elevated creatinine kinase MB-isoenzyme (≥ 5.0 ng per milliliter)
  • elevated NT-pro-BNP (≥ 450 pg per milliliter),
  • ST-segment depression (≥ 0.5 mm)
  • or TIMI risk score (\> 2)
  • women who have elevated cardiac enzymes after non-cardiac surgery will also be considered.

You may not qualify if:

  • ST-elevation myocardial infarction,
  • cardiogenic shock,
  • congestive heart failure,
  • hemodynamic instability,
  • use of fibrinolytic therapy in the last 96 hours,
  • current bleeding or bleeding disorder within the last 3 months that required transfusion,
  • pregnancy,
  • contraindication to any study medication. i.e.heparin, clopidogrel, or glycoprotein IIb/III inhibitor,
  • PCI in the last 6 months,
  • prior CABG,
  • inability to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Anthony A Bavry, M.D., MPH

    Universtiy of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2015

First Posted

February 6, 2015

Study Start

April 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 16, 2015

Record last verified: 2015-02