Metformin in Diabetic Patients Undergoing Coronary Angiography (NO-STOP)

April 11, 2022 updated by: Giulio Stefanini, Humanitas Hospital, Italy

Metformin Continuation Safety in Diabetic Patients Undergoing Coronary Angiography

The present study aims to evaluate the strict application of the 2018 European Society of Cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients have taken metformin immediately before angiography and withhold metformin if renal function deteriorates.

The aim of this study is to assess the safety of metformin in diabetic patients undergoing coronary angiography in terms of risk of lactic acidosis and to individuate eventual predictors of augmented lactate after coronary angiography.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is designed as an open-label (both physician and participant know that metformin will not be discontinued before PCI and in the following 48 hours), prospective, single arm study.

In our historical cohort of diabetic patients taking metformin, we observed a mean value of lactate of 1.2+0.7 mmol/l.

A total of 150 patients will be enrolled. Patients with any deviations from the study protocol will be enrolled in a parallel observational registry.

The study consists of a screening phase, a 30-day observational phase, and an end-of-follow-up visit or phone interview. The total duration of participation in the study for each participant is approximately 30 days.

Study Type

Interventional

Enrollment (Anticipated)

150

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 Contact

Study Contact Backup

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Humanitas Research Hospital
        • Contact:
        • Principal Investigator:
          • Mauro Chiarito, MD
        • Principal Investigator:
          • Giulio Stefanini, Prof
        • Sub-Investigator:
          • Jorge Sanz-Sanchez, MD

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:

  • Diabetic patients treated with metformin undergoing coronary angiography.

Exclusion Criteria:

  • Known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 * estimated glomerular filtration rate; e.g.: 167 ml in a patients with an eGFR of 45 ml/min/1.73m2).
  • Moderate to severe impairment of renal function (eGFR<45 ml/min).
  • Moderate to severe impairment of liver function (Child-Pugh class B or C).
  • Severely impaired left ventricular ejection fraction (LVEF <35%).
  • Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction).
  • Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4).
  • Patients scheduled for cardiac surgery in the following 5 days.
  • Inability to provide informed consent.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin continuation
Drug: Metformin
Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in lactate of 20%
Time Frame: From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography
Lactate will be measured from a venous sampling at three different time points, before coronary angiography, the day after (not mandatory) and 3 days after coronary angiography
From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast-associated acute kidney injury after coronary angiography.
Time Frame: From 0 to 7 days after coronary angiography
Contrast-associated acute kidney injury was defined according to the KDIGO definition: increase in serum creatinine of 0.3 mg/dl within 48 hours from coronary angiography or >50% within 7 days (if creatinine after 7 days is available) or urine output of <0.5 ml/kg/hour for at least 6 hours
From 0 to 7 days after coronary angiography
Metformin associated lactic acidosis
Time Frame: At 24 and 72 hours after coronary angiography
Lactic acidosis was defined as pH less than or equal to 7.35 and lactatemia greater than 2.2 mmol/L
At 24 and 72 hours after coronary angiography

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: Within 30 days after the index coronary angiography
All cause mortality
Within 30 days after the index coronary angiography

Collaborators and Investigators

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

Sponsor

Humanitas Hospital, Italy

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

Helpful Links

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)

January 15, 2020

Primary Completion (Actual)

April 11, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The data that support the findings of this study will be available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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