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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years On metformin therapy Angiography for ACS or elective non-ACS related indications Informed consent received Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin Continuation<br>Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography. | Drug: Metformin<br>* Continuation of Metformin<br>|
| No Intervention: Metformin Interruption<br>Patients undergoing angiography will interrupt their metformin for 48 hours post angiography. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| All cause mortality at hospital discharge | Death in hospital | Duration of hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metformin, diabetes, pci, percutaneous coronary intervention, unstable angina, acute coronary syndrome