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Completed

NCT Number: NCT02655757

Effect of Sitagliptin on Progression of Coronary Intermediate Lesion

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The General Hospital of PLA

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically proven Coronary Intermediate Lesion.

Exclusion criteria

  • Allergy or hypersensitivity to any of the drug's components.
  • Severe liver failure, moderate or severe kidney failure
  • Malignant disease.
  • Active infectious disease.
  • Pregnancy or breastfeeding.

Treatment and study plan

Sitagliptin

Drug

5 mg, 1 tablet per day for 12 months

Other names: JANUVIA

Placebo

Drug

Placebo,1 tablet per day for 12 months

Primary outcomes

  1. Changes in late lumen loss of target lesion

    Time frame: Changes from baseline in late lumen loss of target lesion at 12 months

    A coronary intermediate lesion in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with 3D QCA(3D Quantitative Coronary Angiography). To measure the changes in target lumen at 12 months.

Secondary outcomes

  1. Incidence rate of MACE

    Time frame: Incidence rate of MACE from baseline to 12 months

    MACE include composite of death, myocardial infarction, or target-vessel revascularization.

Sponsors and collaborators

Lead sponsor

Li Bo

Other

Registry information

Official study title

Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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