Acute Coronary SyndromePhase 4NCT03980990
Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
A Phase 4 study testing Metformin in people with Acute Coronary Syndrome and Unstable Angina, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Unstable Angina, Diabetes Mellitus
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2019to 17 Jun 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
- Age ≥ 18 years
- On metformin therapy
- Angiography for ACS or elective non-ACS related indications
- Informed consent received
Who cannot join
- Cardiogenic shock prior to randomization
- Cardiac arrest prior to randomization
- Established severe CKD (eGFR<30, or on dialysis)
- Chronic liver disease
- Need for CABG within 48 hours of hospitalization
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N0W8
Jay Shavadia, MD, 3066553932, jss372@usask.ca
Jay Shavadia, MD
About this study
This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography.
- Being tested
- Metformin
- Keywords
- metformin, diabetes, pci, percutaneous coronary intervention, unstable angina, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Continuation of Metformin
| Study group | Role | What they receive |
|---|---|---|
| Metformin Continuation | Experimental | Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography. Receives: Drug: Metformin |
| Metformin Interruption | No intervention | Patients undergoing angiography will interrupt their metformin for 48 hours post angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactic Acidosis
Lactate Level >5 mmol/L and HCO3<18
Measured: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
Secondary outcomes (2)
Acute Kidney Injury
Rise in baseline creatinine >/= 25% or 27 umol/L
Measured: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
All cause mortality at hospital discharge
Death in hospital
Measured: Duration of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start17 Jun 2019
- Primary completion17 Jun 2020 (estimated)
- Study completion17 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Shavadia, University of Saskatchewan
- Investigators
- Jay Shavadia, MD, Principal investigator, University of Saskatchewan, Department of Medicine, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980990
- Sponsor's protocol ID
- OA-UofS-778
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.
PubMed 20393934Misbin RI, Green L, Stadel BV, Gueriguian JL, Gubbi A, Fleming GA. Lactic acidosis in patients with diabetes treated with metformin. N Engl J Med. 1998 Jan 22;338(4):265-6. doi: 10.1056/NEJM199801223380415. No abstract available.
PubMed 9441244Oktay V, Calpar Cirali I, Sinan UY, Yildiz A, Ersanli MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017 Nov;18(5):334-339. doi: 10.14744/AnatolJCardiol.2017.7836. Epub 2017 Oct 31.
PubMed 29111980Zeller M, Labalette-Bart M, Juliard JM, Potier L, Feldman LJ, Steg PG, Cottin Y, Roussel R. Metformin and contrast-induced acute kidney injury in diabetic patients treated with primary percutaneous coronary intervention for ST segment elevation myocardial infarction: Amulticenter study. Int J Cardiol. 2016 Oct 1;220:137-42. doi: 10.1016/j.ijcard.2016.06.076. Epub 2016 Jun 23.
PubMed 27376570Maznyczka A, Myat A, Gershlick A. Discontinuation of metformin in the setting of coronary angiography: clinical uncertainty amongst physicians reflecting a poor evidence base. EuroIntervention. 2012 Jan;7(9):1103-10. doi: 10.4244/EIJV7I9A175.
PubMed 21959259
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03980990
- Acronym / sponsor ID
- OA-UofS-778
- Keywords
- metformin, diabetes, pci, percutaneous coronary intervention, unstable angina, acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 17 Jun 2020 (estimated)
- Study completion
- 17 Jun 2020 (estimated)
- First posted
- 10 Jun 2019 (actual)
- 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.
This pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (T2D) following invasive coronary angiography. Metformin will be continued until coronary angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Metformin Continuation | Experimental | Drug: MetforminPatients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography. |
| Metformin Interruption | No intervention | –Patients undergoing angiography will interrupt their metformin for 48 hours post angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- On metformin therapy
- Angiography for ACS or elective non-ACS related indications
- Informed consent received
Key exclusion criteria (6 listed)
- Cardiogenic shock prior to randomization
- Cardiac arrest prior to randomization
- Established severe CKD (eGFR<30, or on dialysis)
- Chronic liver disease
- Need for CABG within 48 hours of hospitalization
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 |
|---|---|---|
| MetforminContinuation of Metformin | Drug | Metformin Continuation |
Primary outcome
Lactic Acidosis
Time frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
Lactate Level >5 mmol/L and HCO3<18
2 secondary outcomes
Acute Kidney Injury
Time frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
All cause mortality at hospital discharge
Time frame: Duration of hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Background: PubMed 20393934Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.
- Background: PubMed 9441244Misbin RI, Green L, Stadel BV, Gueriguian JL, Gubbi A, Fleming GA. Lactic acidosis in patients with diabetes treated with metformin. N Engl J Med. 1998 Jan 22;338(4):265-6. doi: 10.1056/NEJM199801223380415. No abstract available.
- Background: PubMed 29111980Oktay V, Calpar Cirali I, Sinan UY, Yildiz A, Ersanli MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017 Nov;18(5):334-339. doi: 10.14744/AnatolJCardiol.2017.7836. Epub 2017 Oct 31.
- Background: PubMed 27376570Zeller M, Labalette-Bart M, Juliard JM, Potier L, Feldman LJ, Steg PG, Cottin Y, Roussel R. Metformin and contrast-induced acute kidney injury in diabetic patients treated with primary percutaneous coronary intervention for ST segment elevation myocardial infarction: Amulticenter study. Int J Cardiol. 2016 Oct 1;220:137-42. doi: 10.1016/j.ijcard.2016.06.076. Epub 2016 Jun 23.
- Background: PubMed 21959259Maznyczka A, Myat A, Gershlick A. Discontinuation of metformin in the setting of coronary angiography: clinical uncertainty amongst physicians reflecting a poor evidence base. EuroIntervention. 2012 Jan;7(9):1103-10. doi: 10.4244/EIJV7I9A175.
- Individual participant dataSharing planned: No
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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.
Jay Shavadia, MD principal investigator
University of Saskatchewan, Department of Medicine, Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Acute Coronary Syndrome and Unstable Angina, run by University of Saskatchewan at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jay Shavadia, MD (3066553932, jss372@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactic Acidosis (time frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)). 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 NCT03980990, which also lists 5 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 20 Jun 2019.