E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effect of three ticagrelor loading dose formulations on the degree and rapidity of platelet aggregation in patients with stable angina referred for coronary angiography |
Effekten av tre olika ticagrelor laddningsdos- formuleringar på grad och snabbhet av blodplättarnas levringsförmåga hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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E.1.1.1 | Medical condition in easily understood language |
Effect of three ticagrelor loading dose formulations on the degree and rapidity of platelet clumbing ability in patients with stable angina referred for coronary angiography. |
Effekten av tre olika ticagrelor laddningsdos formuleringar på graden och snabbhet av blodplättarnas levringsförmåga hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen. |
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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 proportion of patients with high on treatment platelet reactivity 20 and 60 minutes after three different ticagrelor loading dose formulations in patients with stable angina referred for coronary angiography |
Andel patienter med hög återstående reaktivitet av blodplättarna 20 och 60 minuter efter tre olika ticagrelor laddningsdos formuleringar hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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E.2.2 | Secondary objectives of the trial |
Residual platelet reactivity 20 and 60 minutes after three different ticagrelor loading dose formulations in patients with stable angina referred for coronary angiography |
Återstående reaktivitet av blodplättarna 20 och 60 minuter efter tre olika ticagrelor laddningsdos formuleringar hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with stable angina referred for coronary angiography
Ability to provide informed consent
Age 18 years or older |
Patienter med stabil kärlkramp remitterade för kranskärlsröntgen
Förmåga att lämna informerat samtycke
18 år eller äldre |
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E.4 | Principal exclusion criteria |
Pregnacy or lactation, chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine, treatment with warfarin or NOAC in the last 4 days, active bleeding or increased risk of bleeding, history of gastrointestinal or geniourinary bleeding in the last 2 months, history of intracranial bleeding, major surgery in the last 4 weeks, severe anaemia or thrombocytopenia, severe liver or renal disease, increased risk of bradycardia, unable to chew tablet. |
Graviditet, amning, kronisk behandling med ticagrelor, prasugrel, clopidogrel eller ticlopidine, behandling med warfarin eller NOAK sista 4 dagar, pågående blödning eller ökad blödningsrisk, magtarm blödning eller urogenital blödning sista 2 månader, känd hjärnblödning, större kirurgi sista 4 veckor, allvarlig blodbrist eller allvarligt lågt antal blodplättar, allvarlig lever eller njursjukdom, ökad risk för låg puls, oförmåga att tugga tablett. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients with high on treatment platelet reactivity 20 and 60 minutes after three different ticagrelor loading dose formulations in patients with stable angina referred for coronary angiography |
Andel patienter med hög återstående reaktivitet av blodplättarna 20 och 60 minuter efter tre olika ticagrelor laddningsdos formuleringar hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
20 and 60 minutes after three different ticagrelor loading dose formulations in patients with stable angina referred for coronary angiography |
20 och 60 minuter efter tre olika ticagrelor laddningsdos formuleringar hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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E.5.2 | Secondary end point(s) |
Residual platelet reactivity 20 and 60 minutes after three different ticagrelor loading dose formulations in patients with stable angina referred for coronary angiography |
Återstående reaktivitet av blodplättarna 20 och 60 minuter efter tre olika ticagrelor laddningsdos formuleringar hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
20 and 60 minutes after three different ticagrelor loading dose formulations in patients with stable angina referred for coronary angiography |
20 och 60 minuter efter tre olika ticagrelor laddningsdos formuleringar hos patienter med stabil kärlkramp remitterade för kranskärlsröntgen |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 |
intakta ticagrelor tablett |
intact ticagrelor tablet |
|
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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LVLS |
Sista besök av sista patient |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |