NCT02744976

Coronary Artery Disease Progression by iMap Intravascular Ultrasound Analysis in Patients With Prediabetes

Completed Phase 4 Last updated 21 April 2022

What this trial tests

Phase 4 trial testing Metformin in Coronary Artery Disease in 70 participants. Completed in 1 September 2021.

Timeline

1 February 2016

Primary endpoint
31 July 2019

1 September 2021

Quick facts

Lead sponsor	Pauls Stradins Clinical University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	1 February 2016
Primary completion	31 July 2019
Estimated completion	1 September 2021
Sites	1 location across Latvia

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Lifestyle recommendations

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Atherosclerosis — all drugs for Atherosclerosis →
• Prediabetic State — all drugs for Prediabetic State →

Sponsor

Pauls Stradins Clinical University Hospital

Who can join

Adults 18 to 75, any sex, with Coronary Artery Disease or Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage plaque volume change over 24 months
  Time frame: 24 months
  Changes in plaque volume in 24 months

Sponsor's own description

Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up.

The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Circulating plasma microRNA-126, microRNA-145, and microRNA-155 and their association with atherosclerotic plaque characteristics.
   Knoka E, Trusinskis K, Mazule M, Briede I, et al · · 2020 · cited 20× · PMID 32377580