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Heart DiseasePhase 3GOPCABENCT00719667

German Off Pump Coronary Artery Bypass in Elderly Study

A Phase 3 study testing coronary artery bypass grafting in people with Heart Disease, run by German Off Pump Coronary Artery Bypass in Elderly Study Group at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Disease
What is being tested?
coronary artery bypass grafting
How many people
2,000 participants
Where
2 sitesGermany
Study dates
Jul 2008to Oct 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • previous heart surgery
  • patient unable to give informed consent

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Herzchirurgie Neustadt/Saale

    Neustadt/Saale, Bavaria, 97616

  • Universität Regensburg

    Regensburg, Bavaria, 93053

Other trials in Germany

About this 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).

Conditions
Heart Disease
Being tested
coronary artery bypass grafting
Keywords
OPCAB, coronary, bypass, grafting, off pump
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coronary artery bypass graftingOther

    on pump off pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: 1 month and 12 month

  2. Myocardial infarction

    Measured: 1 month and 12 month

  3. Stroke

    Measured: 1 month and 12 month

  4. Any revascularisation

    Measured: 1 month and30 month

  5. renal failure

    Measured: 1 month and 12 month

Secondary outcomes (3)

  1. ventilation time

    Measured: post op

  2. blood transfusion

    Measured: post op

  3. length of stay in intensive-care unit

    Measured: post op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719667
Sponsor's protocol ID
op 001
Acronym
GOPCABE
Status last verified
Oct 2011
First submitted
20 Jul 2008
Last updated
18 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Diegeler A, Borgermann J, Kappert U, Hilker M, Doenst T, Boning A, Albert M, Farber G, Holzhey D, Conradi L, Riess FC, Veeckmann P, Minorics C, Zacher M, Reents W. Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients. Circulation. 2019 Apr 16;139(16):1865-1871. doi: 10.1161/CIRCULATIONAHA.118.035857.

    PubMed 30732456

  • Faerber G, Zacher M, Reents W, Boergermann J, Kappert U, Boening A, Diegeler A, Doenst T; GOPCABE investigators. Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial. PLoS One. 2017 Aug 30;12(8):e0184038. doi: 10.1371/journal.pone.0184038. eCollection 2017.

    PubMed 28854266

  • Diegeler A, Borgermann J, Kappert U, Breuer M, Boning 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.

    PubMed 23477657

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing coronary artery bypass grafting in people with Heart Disease, run by German Off Pump Coronary Artery Bypass in Elderly Study Group at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 1 month and 12 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00719667, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2011.

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