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

Phase 4

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

• Registration Number: NCT03980990
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-10
• Study Start: 2019-06-17
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20
• Primary Completion: 2020-06-17
• Study Completion: 2020-06-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin Continuation	Metformin	Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada