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

June 18, 2019 updated by: Jay Shavadia, University of Saskatchewan
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N0W8
        • Recruiting
        • Royal University Hospital
        • Contact:
        • Principal Investigator:
          • Jay Shavadia, MD
        • Sub-Investigator:
          • Rajan Minhas, MD
        • Sub-Investigator:
          • Haissam Haddad, MD
        • Sub-Investigator:
          • Colin Pearce, MD
        • Sub-Investigator:
          • Gudrun Caspar-Bell, MD
        • Sub-Investigator:
          • Alex Zhai, MD
        • Sub-Investigator:
          • Calvin Wells, MD
        • Sub-Investigator:
          • Jason Orvold, MD
        • Sub-Investigator:
          • Udoka Okpalauwaekwe, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactic Acidosis
Time Frame: 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
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
Time Frame: 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
48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)
All cause mortality at hospital discharge
Time Frame: Duration of hospital admission
Death in hospital
Duration of hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Jay Shavadia, MD, University of Saskatchewan, Department of Medicine, Division of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Anticipated)

June 17, 2020

Study Completion (Anticipated)

June 17, 2020

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA-UofS-778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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