Coronary Artery DiseasePhase 4StaRT-CABGNCT01715714
Statin Recapture Therapy Before Coronary Artery Bypass Grafting
A Phase 4 study testing Statin Recapture Therapy in people with Coronary Artery Disease, run by University of Cologne at 10 sites in Germany.
Trial summary
Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at risk for postoperative complications after surgery. The StaRT-CABG trial is the first large-scale (2,630 patients) that will investigate whether an additional treatment with statins (lipid-lowering medication) in high doses… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Statin Recapture Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,630 participants
- Where
- 10 sitesGermany
- Study dates
- 7 Nov 2012to 27 Sep 2020
- Phase
- Phase 4
- 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
- Patients on chronic statin treatment (>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures
- Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
- Age ≥ 18 years
- Written informed consent
Who cannot join
- Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
- Acute ST-segment-elevation myocardial infarction (STEMI)
- NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission
- History of atrial fibrillation or muscle disease (myopathy)
- Current renal (creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)
- Inability of oral drug intake
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
University of Aachen
Aachen, North Rhine-Westphalia, 52074
Heart Center Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616
Heart Center Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
University of Bochum
Bochum, North Rhine-Westphalia
University of Bonn
Bonn, North Rhine-Westphalia, 53127
University of Cologne
Cologne, North Rhine-Westphalia, 50924
University of Essen
Essen, North Rhine-Westphalia, 45122
Heart Center Freiburg-Bad Krozingen
Freiburg im Breisgau, Baden-Wurttemberg, 79106
University of Muenster
Münster, North Rhine-Westphalia, 48149
Helios Heart Center Wuppertal
Wuppertal, North Rhine-Westphalia, 42117
About this study
Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at risk for postoperative complications after surgery. The StaRT-CABG trial is the first large-scale (2,630 patients) that will investigate whether an additional treatment with statins (lipid-lowering medication) in high doses before CABG surgery can reduce the incidence of major post-surgery complications including death, myocardial infarction and stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in Germany and is expected to provide relevant clinical data on the efficacy of this novel treatment in order to optimize the care for all patients undergoing CABG.
Read the detailed description
Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiocerebral events (≈15% MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence shows that cardioprotection in patients receiving chronic statin treatment can be further improved by a high-dose statin 'recapture' therapy given shortly before an ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems particularly promising, as myocardial injury, surgery-related inflammation and pre-existing patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind and placebo-controlled trial that aims to test whether an acute high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach in order to optimize the care for all CAD patients undergoing CABG with broad clinical implications on current clinical practice and existing guidelines.
- Conditions
- Coronary Artery Disease
- Being tested
- Statin Recapture Therapy, Placebo
- Keywords
- Coronary Artery Disease, Statins, Coronary Artery Bypass Grafting, Cardiac Surgery
- 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.
Statin Recapture TherapyDrug
Also called Simvastatin 80 mg, Atorvastatin 80 mg, Pravastatin 40 mg, Fluvastatin 80 mg
Given 12h and 2h before CABG
PlaceboDrug
Given 12h and 2h before CABG.
| Study group | Role | What they receive |
|---|---|---|
| Statin Recapture Therapy | Active comparator | Oral statin reload of patients at 12 and 2 hours before CABG using the maximal dose of the chronically prescribed statin* on admission. (*simvastatin 80 mg, atorvastatin 80 mg, fluvastatin 80 mg or pravastatin 40 mg) Receives: Drug: Statin Recapture Therapy |
| Placebo | Placebo comparator | Placebo given orally 12 hrs and 2 hrs before CABG Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiocerebral events (MACCE) within 30 days after CABG.
Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA).
Measured: 30 days after Surgery
Secondary outcomes (6)
Major adverse cardiac events
Composite outcome consisting cardiac mortality and non-fatal MI within 30 days after surgery.
Measured: 30 days after Surgery
Length of stay
Length of stay on intensive care unit (ICU) and hospital
Measured: within the first 15 days after surgery (plus or minus 5 days)
Repeat coronary revascularisation
Repeat coronary revascularisation (PCI or CABG)
Measured: 30 days after surgery
Mortality at 12 months
All-cause mortality at 12 months
Measured: 12 months after surgery
Wound Infections
Surgical site wound infections.
Measured: 30 days after surgery
Atrial fibrillation
New-onset postoperative atrial fibrillation
Measured: within the first 15 days after surgery (plus or minus 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study start7 Nov 2012
- Primary completion24 Apr 2019
- Study completion27 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, PD Dr. Oliver J. Liakopoulos, University of Cologne
- Investigators
- Oliver J Liakopoulos, MD, PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715714
- Sponsor's protocol ID
- Uni-Koeln-1341
- Other IDs
- 2011-001795-19, DRKS00000753
- Acronym
- StaRT-CABG
- Status last verified
- Jul 2022
- First submitted
- 18 Oct 2012
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liakopoulos OJ, Kuhn EW, Hellmich M, Kuhr K, Krause P, Reuter H, Thurat M, Choi YH, Wahlers T; StaRT-CABG Investigators. Statin Recapture Therapy before Coronary Artery Bypass Grafting Trial: Rationale and study design of a multicenter, randomized, double-blinded controlled clinical trial. Am Heart J. 2015 Jul;170(1):46-54, 54.e1-2. doi: 10.1016/j.ahj.2015.04.015. Epub 2015 Apr 17.
PubMed 26093863
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Recapture Therapy Before Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01715714
- Acronym / sponsor ID
- StaRT-CABG / Uni-Koeln-1341
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Statins, Coronary Artery Bypass Grafting, Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,630 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 7 Nov 2012 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 27 Sep 2020 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at risk for postoperative complications after surgery. The StaRT-CABG trial is the first large-scale (2,630 patients) that will investigate whether an additional treatment with statins (lipid-lowering medication) in high doses before CABG surgery can reduce the incidence of major post-surgery complications including death, myocardial infarction and stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in Germany and is expected to provide relevant clinical data on the efficacy of this novel treatment in order to optimize the care for all patients undergoing CABG.
Detailed description
Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiocerebral events (≈15% MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence shows that cardioprotection in patients receiving chronic statin treatment can be further improved by a high-dose statin 'recapture' therapy given shortly before an ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems particularly promising, as myocardial injury, surgery-related inflammation and pre-existing patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind and placebo-controlled trial that aims to test whether an acute high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach in order to optimize the care for all CAD patients undergoing CABG with broad clinical implications on current clinical practice and existing guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin Recapture Therapy | Active comparator | Drug: Statin Recapture TherapyOral statin reload of patients at 12 and 2 hours before CABG using the maximal dose of the chronically prescribed statin* on admission. (*simvastatin 80 mg, atorvastatin 80 mg, fluvastatin 80 mg or pravastatin 40 mg) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given orally 12 hrs and 2 hrs before CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients on chronic statin treatment (>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures
- Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
- Age ≥ 18 years
- Written informed consent
Key exclusion criteria (6 listed)
- Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
- Acute ST-segment-elevation myocardial infarction (STEMI)
- NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission
- History of atrial fibrillation or muscle disease (myopathy)
- Current renal (creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin Recapture TherapyAlso: Simvastatin 80 mg, Atorvastatin 80 mg, Pravastatin 40 mg, Fluvastatin 80 mgGiven 12h and 2h before CABG | Drug | Statin Recapture Therapy |
| PlaceboGiven 12h and 2h before CABG. | Drug | Placebo |
Primary outcome
Major adverse cardiocerebral events (MACCE) within 30 days after CABG.
Time frame: 30 days after Surgery
Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA).
6 secondary outcomes
Major adverse cardiac events
Time frame: 30 days after Surgery
Length of stay
Time frame: within the first 15 days after surgery (plus or minus 5 days)
Repeat coronary revascularisation
Time frame: 30 days after surgery
Mortality at 12 months
Time frame: 12 months after surgery
Wound Infections
Time frame: 30 days after surgery
Atrial fibrillation
Time frame: within the first 15 days after surgery (plus or minus 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 26093863Liakopoulos OJ, Kuhn EW, Hellmich M, Kuhr K, Krause P, Reuter H, Thurat M, Choi YH, Wahlers T; StaRT-CABG Investigators. Statin Recapture Therapy before Coronary Artery Bypass Grafting Trial: Rationale and study design of a multicenter, randomized, double-blinded controlled clinical trial. Am Heart J. 2015 Jul;170(1):46-54, 54.e1-2. doi: 10.1016/j.ahj.2015.04.015. Epub 2015 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver J Liakopoulos, MD, PhD principal investigator
University of Cologne
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Statin Recapture Therapy in people with Coronary Artery Disease, run by University of Cologne at 10 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 4 inclusion and 6 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Major adverse cardiocerebral events (MACCE) within 30 days after CABG. (time frame: 30 days after Surgery). 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 NCT01715714, which also lists 1 linked publication.
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 22 Jul 2022.