Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure (REVIVED-BCIS2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by King's College London
Sponsor:
Collaborators:
National Institute for Health Research (Health Technology Assessment Programme)
London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
University of York (Centre for Health Economics)
Guy's and St Thomas' Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Divaka Perera, King's College London
ClinicalTrials.gov Identifier:
NCT01920048
First received: August 3, 2013
Last updated: August 8, 2013
Last verified: August 2013

August 3, 2013
August 8, 2013
August 2013
March 2019   (final data collection date for primary outcome measure)
All-cause death or Hospitalization for Heart Failure [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01920048 on ClinicalTrials.gov Archive Site
  • Quality of Life Scores and Functional Status [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Left Ventricular Ejection Fraction [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
  • Cardiovascular death, myocardial infarction, cerebrovascular accident, major bleeding or unplanned revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiovascular Death [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
  • Appropriate Implantable Cardioverter Defibrillator Therapy [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Acute Myocardial Infarction [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
  • Unplanned further revascularization [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
  • Brain-type Natriuretic Peptide level [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Major Bleeding [ Time Frame: 6 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
Same as current
Health Service Resource Use [ Time Frame: 1 to 66 months (min follow-up duration: 24 months) ] [ Designated as safety issue: No ]
Health Economic Analysis
Same as current
 
Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure
REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED): a Randomized Comparison of Percutaneous Coronary Intervention (With Optimal Medical Therapy) Versus Optimal Medical Therapy Alone for Treatment of Heart Failure Secondary to Coronary Disease

This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Cardiomyopathy
  • Procedure: Percutaneous Coronary Intervention
    Other Name: Coronary angioplasty/stents
  • Drug: Drug Therapy for Heart Failure
    The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines
  • Device: Device Therapy for Heart Failure
    The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.
  • Experimental: Percutaneous Coronary Intervention and Optimal Medical Therapy
    Interventions:
    • Procedure: Percutaneous Coronary Intervention
    • Drug: Drug Therapy for Heart Failure
    • Device: Device Therapy for Heart Failure
  • Active Comparator: Optimal Medical Therapy alone
    Intervention: Drug: Drug Therapy for Heart Failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
March 2019
March 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

ALL of the following:

  1. Poor left ventricular function (EF≤30%)
  2. Extensive coronary disease (BCIS-1 Jeopardy Score ≥6)
  3. Viable myocardium in ≥30% of dysfunctional segments

Main Exclusion Criteria:

  1. Significant angina (≥Canadian Cardiovascular Society class 3)
  2. Myocardial infarction < 6 weeks previously

Other Exclusions

  1. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Balloon Pump/left ventricular assist device therapy <72 hours prior to randomization
  2. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Carioverter Defbrillator discharges <72 hours prior to randomization
  3. More than mild aortic stenosis or mild aortic regurgitation on echocardiography
  4. Contra-indications to percutaenous cornoary intervention, including contra-indications to Aspirin or Clopidogrel or Heparin
  5. Age <18 yrs
  6. Bleeding diathesis or Warfarin therapy with INR (International Normalized Ration)>3.5
  7. Active internal bleeding (except menstruation)
  8. Platelet count < 100,000 cells/mm3) at randomization
  9. Hemoglobin < 90 g/L at randomization
  10. Estimated Glomerular Filtration Rate < 25 ml/min, unless established on dialysis
  11. Women who are pregnant
  12. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
  13. Life expectancy < 1 yr due to non-cardiac pathology
Both
18 Years and older
No
Contact: Richard Evans +44 20 7927 2665 Richard.Evans@lshtm.ac.uk
Contact: Rosemary Knight +44 20 7927 2473 Rosemary.Knight@lshtm.ac.uk
United Kingdom
 
NCT01920048
ISRCTN45979711, ISRCTN45979711
Yes
Divaka Perera, King's College London
King's College London
  • National Institute for Health Research (Health Technology Assessment Programme)
  • London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
  • University of York (Centre for Health Economics)
  • Guy's and St Thomas' Hospital NHS Foundation Trust
Principal Investigator: Divaka Perera, MB BChir, MA, MD, FRCP King's College London
King's College London
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP