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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980990
• Other study ID #: OA-UofS-778
• Status: Recruiting
• Phase: Phase 4
• Start date: June 17, 2019
• Est. completion date: June 17, 2020

Study information

• Verified date: June 2019
• Source: University of Saskatchewan
• Contact: Jay Shavadia, MD
• Phone: 3066553932
• Email: jss372[@]usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Diabetes Mellitus
• Metformin Adverse Reaction
• Unstable Angina

Intervention

Drug:
• Metformin
Continuation of Metformin

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

Oktay V, Calpar Çirali I, Sinan ÜY, 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. — View Citation

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;(4):CD002967. doi: 10.1002/14651858.CD002967.pub4. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute Kidney Injury	Rise in baseline creatinine >/= 25% or 27 umol/L	48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
Secondary	All cause mortality at hospital discharge	Death in hospital	Duration of hospital admission