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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03980990
Enrollment
500
Registered
2019-06-10
Start date
2019-06-17
Completion date
2020-06-17
Last updated
2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

DRUGMetformin

Continuation of Metformin

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Lactic Acidosis48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)Lactate Level \>5 mmol/L and HCO3\<18

Secondary

MeasureTime frameDescription
Acute Kidney Injury48-72 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 dischargeDuration of hospital admissionDeath in hospital

Countries

Canada

Contacts

Primary ContactJay Shavadia, MD
jss372@usask.ca3066553932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026