CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,136 enrolled
Drug / intervention
Active Medication Alone +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Left ventricular ejection fraction less than 35% documented by echocardiogram, left ventriculogram, CMR, or gated SPECT
  • Coronary artery disease anatomy suitable for surgical revascularization
  • No left main coronary artery disease (≥50% stenosis) for patients in the medical therapy only arm
  • Canadian Cardiovascular Society angina class less than III for patients in the medical therapy only arm
Key exclusion· 8
  • Recent acute myocardial infarction judged to be an important cause of left ventricular dysfunction
  • Cardiogenic shock within 72 hours of randomization, defined by need for intraaortic balloon support or intravenous inotropic support
  • History of more than one prior coronary artery bypass operation
  • Aortic valvular heart disease clearly indicating need for aortic valve repair or replacement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00023595
NCT00023595Phase 3Completed

Surgical Treatment for Ischemic Heart Failure (STICH)

Duke University·interventional·Posted Sep 11, 2001·Updated Sep 19, 2019

In Brief

A Phase 3 clinical trial evaluating CABG surgery plus MED, Active Medication Alone, and 1 other intervention for Cardiovascular Diseases and 3 related conditions. Completed, enrolled 2,136 participants across 1 site.

Detailed Summary

This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2001
Enrollment StartJan 1, 2002
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 24.8 years ago

Interventions

CABG surgery plus MEDprocedure

CABG plus standard medication management for Coronary Artery Disease

Active Medication Alonedrug

Standard medication for coronary artery disease and heart failure management.

CABG plus MED and SVRprocedure

H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone