German Off Pump Coronary Artery Bypass in Elderly Study (GOPCABE)

This study has been completed.
Sponsor:
Collaborators:
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie
Information provided by (Responsible Party):
PD Dr. Michael Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group
ClinicalTrials.gov Identifier:
NCT00719667
First received: July 20, 2008
Last updated: October 17, 2011
Last verified: October 2011

July 20, 2008
October 17, 2011
July 2008
October 2011   (final data collection date for primary outcome measure)
  • All cause mortality [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: No ]
  • Any revascularisation [ Time Frame: 1 month and30 month ] [ Designated as safety issue: No ]
  • renal failure [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00719667 on ClinicalTrials.gov Archive Site
  • ventilation time [ Time Frame: post op ] [ Designated as safety issue: No ]
  • blood transfusion [ Time Frame: post op ] [ Designated as safety issue: No ]
  • length of stay in intensive-care unit [ Time Frame: post op ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
German Off Pump Coronary Artery Bypass in Elderly Study
German Off Pump Coronary Artery Bypass in Elderly Study

Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old.

Hypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Heart Disease
Other: coronary artery bypass grafting
on pump off pump
Not Provided
Diegeler A, Börgermann J, Kappert U, Breuer M, Böning A, Ursulescu A, Rastan A, Holzhey D, Treede H, Rieß FC, Veeckmann P, Asfoor A, Reents W, Zacher M, Hilker M; GOPCABE Study Group. Off-pump versus on-pump coronary-artery bypass grafting in elderly patients. N Engl J Med. 2013 Mar 28;368(13):1189-98. doi: 10.1056/NEJMoa1211666. Epub 2013 Mar 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • older or 75 years
  • indication for elective bypass operation
  • patient has signed written consent before randomization

Exclusion Criteria:

  • previous heart surgery
  • patient unable to give informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00719667
op 001
Yes
PD Dr. Michael Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group
German Off Pump Coronary Artery Bypass in Elderly Study Group
  • Institut für Klinisch-Kardiovaskuläre Forschung GmbH
  • Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie
Principal Investigator: Anno Diegeler, Professor Herzchirurgie Bad Neustadt/Saale
Study Chair: Michael Hilker, PD Universität Regensburg
German Off Pump Coronary Artery Bypass in Elderly Study Group
October 2011

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