Recruiting

Metformin

Sponsor:

University of Saskatchewan

Code:

NCT03980990

Conditions

Acute Coronary Syndrome

Unstable Angina

Diabetes Mellitus

Metformin Adverse Reaction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metformin

Study Details

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.

Conditions

Acute Coronary Syndrome

Unstable Angina

Diabetes Mellitus

Metformin Adverse Reaction

Study ID

NCT03980990

Start date

Jun 17, 2019

Status verified date

Jun, 2019

Completion date

Jun 17, 2020

Anticipated

Primary completion date

Jun 17, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Metformin Continuation

Patients undergoing angiography will continue their metformin without interruption at their next scheduled dose following angiography.

no intervention: Metformin Interruption

Patients undergoing angiography will interrupt their metformin for 48 hours post angiography.

Interventions

Metformin

Continuation of Metformin

Primary outcome measure

  • Lactic Acidosis [ Time Frame: 48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization) ]

Central Contacts and Locations

Central contacts

Jay Shavadia, MD

3066553932jss372@usask.ca

Locations

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N0W8

Contacts

Jay Shavadia, MD

3066553932jss372@usask.ca

Principal Investigator:

Jay Shavadia, MD

More Information

Sponsor

University of Saskatchewan

Last update posted

Jun 20, 2019

Last verified

Jun, 2019

Keywords

  • metformin
  • diabetes
  • pci
  • percutaneous coronary intervention
  • unstable angina
  • acute coronary syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2019-06-20.