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

University of Saskatchewan500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Acute Coronary Syndrome Unstable Angina Diabetes Mellitus Metformin Adverse Reaction

Interventions

MetforminDRUG

Continuation of Metformin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal University Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

Outcomes

Primary Outcomes

Lactic Acidosis

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

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

Secondary Outcomes

Acute Kidney Injury

Rise in baseline creatinine \>/= 25% or 27 umol/L

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

All cause mortality at hospital discharge

Death in hospital

Time frame: Duration of hospital admission

Central Contacts

Jay Shavadia, MD

CONTACT

3066553932 jss372@usask.ca

Data from ClinicalTrials.gov

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