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Diabetes MellitusPhase 4NO-STOPNCT04766008

Metformin in Diabetic Patients Undergoing Coronary Angiography

A Phase 4 study testing Metformin in people with Diabetes Mellitus and Coronary Artery Disease, run by Humanitas Hospital, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
15 Jan 2020to 30 Apr 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetic patients treated with metformin undergoing coronary angiography.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Giulio Stefanini, MD, PhD contact

+390282247384

giulio.stefanini@gmail.com

Mauro Chiarito, MD contact

+390282247009

mauro.chiarito@humanitas.it

Italy1 site, 1 recruiting

  • Humanitas Research Hospital

    Rozzano, Milan, 20089

    Giulio Stefanini, Prof, 0282247384, giulio.stefanini@hunimed.eu

    Mauro Chiarito, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Metformin
Keywords
metformin, coronary angiography, diabetes mellitus, lactic acidosis
Medical subject headings
Diabetes Mellitus, Coronary Artery Disease, Acidosis, Lactic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI.

Study groups in NCT04766008
Study groupRoleWhat they receive
Metformin continuationExperimentalNot described
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase in lactate of 20%

    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

    Measured: From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography

Secondary outcomes (2)

  1. Contrast-associated acute kidney injury 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

    Measured: From 0 to 7 days after coronary angiography

  2. Metformin associated lactic acidosis

    Lactic acidosis was defined as pH less than or equal to 7.35 and lactatemia greater than 2.2 mmol/L

    Measured: At 24 and 72 hours after coronary angiography

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start15 Jan 2020
  3. Primary completion11 Apr 2022
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04766008
Sponsor's protocol ID
20190918
Acronym
NO-STOP
Status last verified
Apr 2022
First submitted
26 Jan 2021
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data that support the findings of this study will be available from the corresponding author on reasonable request.

Publications

  • Pfisterer ME, Zellweger MJ. Therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009 Oct 1;361(14):1407; author reply 1409-10. doi: 10.1056/NEJMc091419. No abstract available.

    PubMed 19797290

  • Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.

    PubMed 8569826

  • 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.

    PubMed 21959259

  • Timmer JR, Ottervanger JP, de Boer MJ, Dambrink JH, Hoorntje JC, Gosselink AT, Suryapranata H, Zijlstra F, van 't Hof AW; Zwolle Myocardial Infarction Study Group. Hyperglycemia is an important predictor of impaired coronary flow before reperfusion therapy in ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2005 Apr 5;45(7):999-1002. doi: 10.1016/j.jacc.2004.12.050.

    PubMed 15808754

  • Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. Reply. N Engl J Med. 2019 Sep 26;381(13):1296-1297. doi: 10.1056/NEJMc1908879. No abstract available.

    PubMed 31553855

  • Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534. doi: 10.4244/EIJY19M01_01. No abstract available.

    PubMed 30667361

  • Parra D, Legreid AM, Beckey NP, Reyes S. Metformin monitoring and change in serum creatinine levels in patients undergoing radiologic procedures involving administration of intravenous contrast media. Pharmacotherapy. 2004 Aug;24(8):987-93. doi: 10.1592/phco.24.11.987.36131.

    PubMed 15338847

  • Nawaz S, Cleveland T, Gaines PA, Chan P. Clinical risk associated with contrast angiography in metformin treated patients: a clinical review. Clin Radiol. 1998 May;53(5):342-4. doi: 10.1016/s0009-9260(98)80005-6.

    PubMed 9630271

  • Laskey WK, Jenkins C, Selzer F, Marroquin OC, Wilensky RL, Glaser R, Cohen HA, Holmes DR Jr; NHLBI Dynamic Registry Investigators. Volume-to-creatinine clearance ratio: a pharmacokinetically based risk factor for prediction of early creatinine increase after percutaneous coronary intervention. J Am Coll Cardiol. 2007 Aug 14;50(7):584-90. doi: 10.1016/j.jacc.2007.03.058. Epub 2007 Jul 30.

    PubMed 17692741

  • Chiarito M, Sanz-Sanchez J, Piccolo R, Condello F, Liccardo G, Maurina M, Avvedimento M, Regazzoli D, Pagnotta P, Garcia-Garcia HM, Mehran R, Federici M, Condorelli G, Diez Gil JL, Reimers B, Ferrante G, Stefanini G. Safety of metformin continuation in diabetic patients undergoing invasive coronary angiography: the NO-STOP single arm trial. Cardiovasc Diabetol. 2023 Feb 6;22(1):28. doi: 10.1186/s12933-023-01744-4.

    PubMed 36747244

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin in people with Diabetes Mellitus and Coronary Artery Disease, run by Humanitas Hospital, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giulio Stefanini, MD, PhD (+390282247384, giulio.stefanini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in lactate of 20% (time frame: From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04766008, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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