Acute Coronary Syndrome, Diabetes Mellitus, Metformin Adverse Reaction, Unstable Angina
Conditions
Keywords
metformin, diabetes, pci, percutaneous coronary intervention, unstable angina, acute coronary syndrome
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.
Interventions
Continuation of Metformin
Sponsors
Study design
Intervention model description
Randomized Controlled Trial
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactic Acidosis | 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) | Lactate Level \>5 mmol/L and HCO3\<18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury | 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) | Rise in baseline creatinine \>/= 25% or 27 umol/L |
| All cause mortality at hospital discharge | Duration of hospital admission | Death in hospital |
Countries
Canada