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

Primary Purpose

Acute Coronary Syndrome, Unstable Angina, Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring metformin, diabetes, pci, percutaneous coronary intervention, unstable angina, acute coronary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
On metformin therapy
Angiography for ACS or elective non-ACS related indications
Informed consent received

Exclusion Criteria:

Cardiogenic shock prior to randomization
Cardiac arrest prior to randomization
Established severe CKD (eGFR<30, or on dialysis)
Chronic liver disease
Need for CABG within 48 hours of hospitalization
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

Sites / Locations

Royal University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Metformin Continuation

Metformin Interruption

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lactic Acidosis

Lactate Level >5 mmol/L and HCO3<18

Secondary Outcome Measures

Acute Kidney Injury

Rise in baseline creatinine >/= 25% or 27 umol/L

All cause mortality at hospital discharge

Death in hospital

Full Information

NCT ID

NCT03980990

First Posted

June 5, 2019

Last Updated

June 18, 2019

Sponsor

University of Saskatchewan

1. Study Identification

Unique Protocol Identification Number

NCT03980990

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

June 17, 2020 (Anticipated)

Study Completion Date

June 17, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin Continuation

Arm Type

Experimental

Arm Description

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

Arm Title

Metformin Interruption

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Continuation of Metformin

Primary Outcome Measure Information:

Title

Lactic Acidosis

Description

Lactate Level >5 mmol/L and HCO3<18

Time Frame

48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)

Secondary Outcome Measure Information:

Title

Acute Kidney Injury

Description

Rise in baseline creatinine >/= 25% or 27 umol/L

Time Frame

48-72 hours (or 72 hours for patients with staged PCI procedures within 48 hours of randomization)

Title

All cause mortality at hospital discharge

Description

Death in hospital

Time Frame

Duration of hospital admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years On metformin therapy Angiography for ACS or elective non-ACS related indications Informed consent received Exclusion Criteria: Cardiogenic shock prior to randomization Cardiac arrest prior to randomization Established severe CKD (eGFR<30, or on dialysis) Chronic liver disease Need for CABG within 48 hours of hospitalization 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jay Shavadia, MD

Phone

3066553932

jss372@usask.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jay Shavadia, MD

Organizational Affiliation

University of Saskatchewan, Department of Medicine, Division of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal University Hospital

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N0W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jay Shavadia, MD

Phone

3066553932

jss372@usask.ca

First Name & Middle Initial & Last Name & Degree

Jay Shavadia, MD

First Name & Middle Initial & Last Name & Degree

Rajan Minhas, MD

First Name & Middle Initial & Last Name & Degree

Haissam Haddad, MD

First Name & Middle Initial & Last Name & Degree

Colin Pearce, MD

First Name & Middle Initial & Last Name & Degree

Gudrun Caspar-Bell, MD

First Name & Middle Initial & Last Name & Degree

Alex Zhai, MD

First Name & Middle Initial & Last Name & Degree

Calvin Wells, MD

First Name & Middle Initial & Last Name & Degree

Jason Orvold, MD

First Name & Middle Initial & Last Name & Degree

Udoka Okpalauwaekwe, MBBS

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20393934

Citation

Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.

Results Reference

background

PubMed Identifier

9441244

Citation

Misbin RI, Green L, Stadel BV, Gueriguian JL, Gubbi A, Fleming GA. Lactic acidosis in patients with diabetes treated with metformin. N Engl J Med. 1998 Jan 22;338(4):265-6. doi: 10.1056/NEJM199801223380415. No abstract available.

Results Reference

background

PubMed Identifier

29111980

Citation

Oktay V, Calpar Cirali I, Sinan UY, Yildiz A, Ersanli MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017 Nov;18(5):334-339. doi: 10.14744/AnatolJCardiol.2017.7836. Epub 2017 Oct 31.

Results Reference

background

PubMed Identifier

27376570

Citation

Zeller M, Labalette-Bart M, Juliard JM, Potier L, Feldman LJ, Steg PG, Cottin Y, Roussel R. Metformin and contrast-induced acute kidney injury in diabetic patients treated with primary percutaneous coronary intervention for ST segment elevation myocardial infarction: Amulticenter study. Int J Cardiol. 2016 Oct 1;220:137-42. doi: 10.1016/j.ijcard.2016.06.076. Epub 2016 Jun 23.

Results Reference

background

PubMed Identifier

21959259

Citation

Maznyczka A, Myat A, Gershlick A. Discontinuation of metformin in the setting of coronary angiography: clinical uncertainty amongst physicians reflecting a poor evidence base. EuroIntervention. 2012 Jan;7(9):1103-10. doi: 10.4244/EIJV7I9A175.

Results Reference

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

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