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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02127996
Other study ID # P01799
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 2015
Est. completion date July 2021

Study information

Verified date June 2018
Source Papworth Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. The procedure risks small but significant damage to the heart muscle downstream of the balloon.

Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut in response to food. It acts by stimulating the release of insulin. In the heart it acts to increase glucose uptake into cardiac muscle. GLP−1 can protect the heart and improve heart muscle performance in people with coronary artery disease in physiological studies. This study which assesses whether GLP−1 protects the heart during coronary angioplasty and stenting.

The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 193
Est. completion date July 2021
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Undergoing elective PCI

- Age over 18

- Able to give informed consent

Exclusion criteria:

- Severe co-morbidity (expected life expectancy < 6 months)

- Nicorandil, glibenclamide, sitagliptin, vildagliptin, saxagliptin, linagliptin, liraglutide, exenatide and insulin use

- Women of child bearing age

- Breast-feeding women

- Myocardial infarction within the previous 3 months

- Baseline elevation of Troponin I before PCI

- Chronic Renal Impairment (serum creatinine > 160 µmol/l)

Study Design


Intervention

Drug:
GLP-1
GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
placebo
Normal saline

Locations

Country Name City State
United Kingdom Papworth Hospital Cambridge Cambridgeshire

Sponsors (1)

Lead Sponsor Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Troponin I level Incidence of Troponin I elevation of > 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure. 6 Hours following angioplasty or stenting
Secondary Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases. From date of randomisation until the date of first event assessed up to 6 months
Secondary Plasma Creatine Kinase - Myocardial Bound (CKMB) level CKMB level on blood test at 6 hours following angioplasty or stenting 6 hours
Secondary Myocardial Flow Grade after Angioplasty or Stenting Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale Measured during procedure
Secondary MACCE Rates MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases. From date of randomisation until the date of first event assessed up to 12 months
Secondary MACCE Rates MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases. From date of randomisation until the date of first event assessed up to 60 months
Secondary Ischaemic symptoms during balloon occlusion Presence or absence or of symptoms of myocardial ischaemia during the procedure Assessed during procedure
Secondary Myocardial Blush Grade following angioplasty or stenting Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale Measured during procedure
Secondary Electrocardiographic (ECG) Changes during procedure Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure Assessed during procedure
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