E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To determine whether an infusion of GLP1 can reduce the occurrence of myocyte necrosis and infarction caused by percutaneous coronary intervention |
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E.1.1.1 | Medical condition in easily understood language |
Angina treated with stenting |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066592 |
E.1.2 | Term | Post procedural myocardial infarction |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002380 |
E.1.2 | Term | Angina of effort |
E.1.2 | System Organ Class | 100000004849 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Undergoing elective PCI • Age over 18 • Able to give informed consent |
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E.4 | Principal 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) |
|
E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Six hours post procedure +/- 1 hour |
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E.5.2 | Secondary end point(s) |
CKMB at 6 hours
TIMI Epicardial Flow Grade and TIMI Myocardial Blush Grade
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
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
TIMI Epicardial Flow Grade and TIMI Myocardial Blush Grade - Assessed at time of procedure
CKMB - measured at 6 hours
MACCE rate - assessed at 6, 12 and 60 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Upon completion of the 60 month followup of the final subject. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |