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

NCT03980990 | Unknown Phase 4 FDA Drug

• 1 other identifier: OA-UofS-778
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Unstable Angina; Diabetes Mellitus; Metformin Adverse Reaction

Keywords

metformin; diabetes; pci; percutaneous coronary intervention; unstable angina; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Lactic Acidosis

  Lactate Level \>5 mmol/L and HCO3\<18

  48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)

Secondary Outcomes (2)

• Acute Kidney Injury

  48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)

• All cause mortality at hospital discharge

  Duration of hospital admission

Study Arms (2)

Metformin Continuation

EXPERIMENTAL

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

Drug: Metformin

Metformin Interruption

NO INTERVENTION

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

Interventions

Metformin DRUG

Continuation of Metformin

Metformin Continuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• On metformin therapy
• Angiography for ACS or elective non-ACS related indications
• Informed consent received

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N0W8, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 20393934 BACKGROUND

• 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.

  PMID: 9441244 BACKGROUND

• 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.

  PMID: 29111980 BACKGROUND

• 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.

  PMID: 27376570 BACKGROUND

• 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.

  PMID: 21959259 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jay Shavadia, MD

  University of Saskatchewan, Department of Medicine, Division of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Shavadia, MD

CONTACT

3066553932; jss372@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 10, 2019
• Study Start: June 17, 2019
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)