Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial

NCT ID: NCT03980990

Last Updated: 2019-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2020-06-17

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome Unstable Angina Diabetes Mellitus Metformin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin Continuation

Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Continuation of Metformin

Metformin Interruption

Patients undergoing angiography will interrupt their metformin for 48 hours post angiography.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin

Continuation of Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. On metformin therapy
3. Angiography for ACS or elective non-ACS related indications
4. Informed consent received

Exclusion Criteria

1. Cardiogenic shock prior to randomization
2. Cardiac arrest prior to randomization
3. Established severe CKD (eGFR\<30, or on dialysis)
4. Chronic liver disease
5. Need for CABG within 48 hours of hospitalization
6. 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jay Shavadia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jay Shavadia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Department of Medicine, Division of Cardiology

Locations

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Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jay Shavadia, MD

Role: CONTACT

3066553932

Facility Contacts

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Jay Shavadia, MD

Role: primary

3066553932

References

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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.

Reference Type BACKGROUND
PMID: 20393934 (View on PubMed)

Misbin 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.

Reference Type BACKGROUND
PMID: 9441244 (View on PubMed)

Oktay 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.

Reference Type BACKGROUND
PMID: 29111980 (View on PubMed)

Zeller 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.

Reference Type BACKGROUND
PMID: 27376570 (View on PubMed)

Maznyczka 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.

Reference Type BACKGROUND
PMID: 21959259 (View on PubMed)

Other Identifiers

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OA-UofS-778

Identifier Type: -

Identifier Source: org_study_id

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