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Coronary Artery Disease (CAD)Phase 2NCT01444235

Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

A Phase 2 study testing Custodiol-N and Custodiol in people with Coronary Artery Disease (CAD), run by Dr. F. Köhler Chemie GmbH at 4 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 the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
Custodiol-N and Custodiol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
4 sitesGermany
Study dates
Mar 2011to Jul 2012
Phase
Phase 2
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The study population will be selected from patients of either sex with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery.
  • Patients >/=35 and </=80 years of age
  • Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation
  • Presence of definite CAD for which surgical intervention is deemed necessary, without evidence of ongoing infarction.
  • Patients with unstable angina can be included as long as there is no objective (negative cardiac isoenzymes in the immediate six hours preceding CABG, current intravenous use of nitrate therapy) or subjective (absence of prolonged symptoms suggestive of coronary insufficiency that do not respond to pharmacologic intervention) evidence of myocardial necrosis.
  • Eligibility for Swan-Ganz-Catheter
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  • Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
  • No evidence of severe organic or psychiatric disease by history or physical examination
  • No history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or no any history of drug abuse or addiction within 12 months of study enrollment.

Who cannot join

  • Patients undergoing valve repair or replacement
  • History of recent (< 6 weeks) Q-wave myocardial infarction
  • Left ventricular ejection fraction < 35% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
  • Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
  • Pregnant or lactating patients
  • Patients who have participated in any other investigational studies within 30 days previous to enrollment
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  • Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
  • Patients with severe chronic obstructive lung disease (FEV1 < 50%)
  • Previous cardiac valvular disease (clinical relevant)
  • Dialysis or creatinine > 2 mmol/L
  • BMS-Stent < 4 weeks
  • DES-Stent < 6 month
  • Guidance depended Plavix therapy

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen

    Essen, 45147

  • Abt. Herzchirugie, Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

    Jena, 07740

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

Other trials in Germany

About this study

Official title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N Versus Custodiol

Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.

Read the detailed description

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (primary endpoint), catecholamine requirement(cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

Being tested
Custodiol-N, Custodiol
Keywords
CAD, ACVB
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Custodiol-NDrug

    Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes

  • CustodiolDrug

    Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused

Study groups in NCT01444235
Study groupRoleWhat they receive
CustodiolActive comparatorAfter cross clamping of the aorta on cardiopulmonary bypass, the Custodiol solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.
Receives: Drug: Custodiol
Custodiol-NExperimentalAfter cross clamping of the aorta on cardiopulmonary bypass, the Custodiol-N solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.
Receives: Drug: Custodiol-N

What is being measured

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

  1. CK-MB area under the curve within 24 hours

    Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp

    Measured: Up to 24 hours after the aortic clamp release

Secondary outcomes (3)

  1. Catecholamine requirement

    Catecholamine requirement on surgical ICU within 24 hours

    Measured: 24 hours (cumulative dose)

  2. CK-MB peak

    CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp

    Measured: Up to day 5

  3. Mortality any time during post-op through Day 30

    Mortality will be documented at any time during post-op through Day 30

    Measured: Up to Day 30

Timeline

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

  1. First posted30 Sep 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMay 2012
  4. Study completionJul 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01444235
Sponsor's protocol ID
CL-N-CSM-III/01/08
Status last verified
May 2013
First submitted
29 Sep 2011
Last updated
17 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Custodiol-N and Custodiol in people with Coronary Artery Disease (CAD), run by Dr. F. Köhler Chemie GmbH at 4 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 9 inclusion and 13 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

CK-MB area under the curve within 24 hours (time frame: Up to 24 hours after the aortic clamp release). 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 NCT01444235.

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 17 May 2013.

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