E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who are candidates for cardiac rehabilitation after documented coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI), who have pre-diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Patients who are candidates for cardiac rehabilitation after documented coronairy artery disease who have pre-diabetes |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064346 |
E.1.2 | Term | STEMI |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036482 |
E.1.2 | Term | Pre-diabetic |
E.1.2 | System Organ Class | 100000004861 |
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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 |
The primary objective of this randomized trial is to reduce the HbA1c levels by 10% through an exercise programme with or without oral anti-diabetic medication in patients with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI), that have pre-diabetes.
Primary endpoint
- The reduction in HbA1c at one year in patients with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI) that have pre-diabetes.
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E.2.2 | Secondary objectives of the trial |
Secondary endpoint
- hsCRP
- LDL cholesterol
- MACE at one year FUP
- Exercise capacity
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria
• • Patients admitted with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI) (inclusion within 2 month after admission)
• Age ≥ 18 years
• Elevated HbA1c levels (HbA1c > 5.8% or > 40 mmol/mol) on admission
• Access to a computer with internet connection
• Written informed consent
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E.4 | Principal exclusion criteria |
Exclusion criteria
• Known diabetics, with or without anti-diabetic medication
• Contra-indications for Metformine use as stated in the medication registration
• Life Expectancy <1 yr
• Physical limitations/restrictions for participation in exercise programme or exercise testing
• Fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 53
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E.5 End points |
E.5.1 | Primary end point(s) |
The reduction in HbA1c at one year in patients with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI) that have pre-diabetes. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- hsCRP
- LDL cholesterol
- MACE at one year FUP
- Exercise capacity
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
in-hospital, 6 months follow up and 1 year follow up |
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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 | No |
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.5 | The trial involves multiple Member States | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 15 |