E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of cardiovascular disease in persons with type 1 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of cardiovascular disease in persons with type 1 diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 main objective is to investigate platelet aggregation in type 1 diabetes (T1D) without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls |
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E.2.2 | Secondary objectives of the trial |
• Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls. • Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D. • Examine the association between platelet aggregation and plaque morphology (expressed as a grayscale) • Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D. • Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors. • Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors. • Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria (T1D) • Type 1 diabetes • Male and female participants, >18 years of age • Capable of giving informed consent
Inclusion criteria (healthy controls) • Healthy, as judged by the exclusion criteria’s below • Male and female participants, >18 years of age • Capable of giving informed consent
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E.4 | Principal exclusion criteria |
Exclusion criteria (T1D) • Pregnancy or breastfeeding (urine HCG is performed on all fertile women) • Non-diabetic kidney disease • Treatment with adenosine diphosphate (ADP)-receptor inhibitors, NSAID within the past 14 days, fish oil or other antithrombotic treatment (vitamin K antagonists and NOAKs) • Liver disease (liver cirrhosis with current impaired liver function defined as alanine-aminotransferase (ALT) more than two times the upper limit at last control) • High risk of thrombosis: o Stroke, TIA or drug eluting stent within the last 6 months o Acute coronary syndrome within the last 6 weeks or within 12 months from complications to acute coronary syndrome • Known hypersensitivity or intolerance to aspirin • Persons who, in the judgement of the investigator, are incapable of participating. • Participation in another intervention study
Exclusion criteria (healthy controls) • Chronic systemic disease • Intake of any antithrombotic medication • Intake of fish oil • Intake of NSAIDs within the past 14 days • Pregnancy or breastfeeding (urine HCG is performed in all fertile women) • Persons who, in the judgement of the investigator, are incapable of participating • Participation in another intervention study |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Investigate platelet aggregation in T1D without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls. Platelet aggregation is determined by arachidonic acid expressed as area under the curve.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be evaluated when all participants have attended visit 2 or 3A. |
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E.5.2 | Secondary end point(s) |
1 Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls. 2 Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D. 3 Examine the association between platelet aggregation and plaque morphology (expressed as a grayscale) 4 Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D. 5 Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries. 6 Investigate whether platelet aggregation can predict progression in plaque volume after two years, independently of other risk factors. 7 Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints no. 1-5 will be evaluated when all participants have attended visit 2 or 3A. The secondary endpoint no. 6 will be evaluated after all participants have attended the 2 year follow-up visit. The secondary endpoint no. 7 will be evaluated after the long-term follow-up data fra registries have been collected. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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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The end of trial in relation to IMP is LPLV at visit 2/3A. The follow-up visit and long-term follow-up do not involve any IMP. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |