A study to investigate the protective effects of Glucagon­like Peptide­1 (GLP-­1) in patients undergoing elective angioplasty and stenting.

Phase 1

• Conditions: To determine whether an infusion of GLP­1 can reduce the occurrence of myocyte necrosis and infarction caused by percutaneous coronary intervention; MedDRA version: 18.0Level: PTClassification code 10066592Term: Post procedural myocardial infarctionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 18.0Level: LLTClassification code 10002380Term: Angina of effortSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001967-22-GB
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-19
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Undergoing elective PCI
• Age over 18
• Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

• Severe co­morbidity (expected life expectancy < 6 months)
• Nicorandil, sulphonylurea, DPP­4 inhibitor, GLP­1 receptor agonist, and insulin use
• Women of child bearing age
• Breast­feeding women
• Myocardial infarction within the previous 6 weeks
• Chronic Renal Impairment (serum creatinine > 200 µmol/l)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether a drip containing GLP­-1 can reduce heart muscle damage during angioplasty or stenting. This is called Myocardial Infarction type 4a (MI4a) and is assessed with a blood test for heart muscle damage called Troponin I following the procedure.;Secondary Objective: Does GLP-­1 given as a drip during angioplasty or stenting affect the long term outcome of the procedure for cardiovascular health, as well as other immediate measures of procedural success.;Primary end point(s): Incidence of myocardial infarction associated with coronary angioplasty or stenting (MI4a) , defined as Troponin I elevation of > 5 x 99th percentile upper reference limit at approximately 6 hours post procedure.;Timepoint(s) of evaluation of this end point: Six hours post procedure +/­- 1 hour

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): CKMB at 6 hours<br><br>TIMI Epicardial Flow Grade and TIMI Myocardial Blush Grade<br><br>MACCE rate up to 60 months (death, stent thrombosis, myocardial infarction, ACS, heart failure, stroke, TIA) – these will be patient reported and confirmed by interrogation of patient hospital records and interrogation of local and national databases. Analysis of this endpoint will take place when all patients have reached 6, 12 and 60 months post­PCI. Ischaemic symptoms and ECG changes during balloon occlusion<br>;Timepoint(s) of evaluation of this end point: TIMI Epicardial Flow Grade and TIMI Myocardial Blush Grade - Assessed at time of procedure<br><br>CKMB - measured at 6 hours<br><br>MACCE rate - assessed at 6, 12 and 60 months