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

University of Saskatchewan

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03980990

OA-UofS-778

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Metformin Continuation

Experimental group

Description:

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

Treatment:

Drug: Metformin

Metformin Interruption

No Intervention group

Description:

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