Clinical trial NCT03980990: Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
Official title: Metformin Continuation Versus Interruption Following Coronary Angiography: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Unstable Angina
Diabetes Mellitus
Metformin Adverse Reaction
Keywords: metformin
diabetes
pci
percutaneous coronary intervention
unstable angina
acute coronary syndrome
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lactic Acidosis
timeFrame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
Secondary outcomes:
measure: Acute Kidney Injury
timeFrame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
measure: All cause mortality at hospital discharge
timeFrame: Duration of hospital admission
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Department of Medicine, Division of Cardiology
name: Jay Shavadia, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.
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. doi: 10.1056/NEJM199801223380415. No abstract available.
citation: 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.
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.
citation: 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.