E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effect of Ticagrelor and Prasugrel in patients with insufficient responding to Clopidogrel after coronary intervention (non-inferiority of Ticagrelor vs. Prasugrel) |
Wirkung von Ticagrelor und Prasugrel bei Patienten mit insuffizientem Ansprechen auf Clopidogrel nach Koronarintervention (Nicht-Unterlegenheit von Ticagrelor gegenüber Prasugrel) |
|
E.1.1.1 | Medical condition in easily understood language |
Ticagrelor vs. Prasugrel in patients with Clopidogrel low response |
Ticagrelor vs. Prasugrel bei Patienten mit unzureichendem Ansprechen auf Clopidogrel |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
|
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 |
Ticagrelor is not inferior to Prasugrel with regard to the inhibition of platelet aggregation in patients with insufficient response to Clopidogrel. |
Ticagrelor ist Prasugrel in Bezug auf Thrombozytenaggregations-hemmung bei Patienten mit insuffizientem Ansprechen auf Clopidogrel nicht unterlegen. |
|
E.2.2 | Secondary objectives of the trial |
The objective of this clinical trial is to measure the degree of the inhibition of platelet aggregation by the two active substances Ticagrelor and Prasugrel in patients, who received a coronary stent implantation and show an insufficient responding to Clopidogrel after this intervention.
The measurement is done by means of full-blood impedance aggregometry using Multiplate Analyzer. |
Ziel dieser klinischen Studie ist es, bei Patienten nach koronarer Stentimplantation und mit insuffizientem Ansprechen auf Clopidogrel das Ausmaß der Hemmung der Thrombozytenaggregation durch Ticagrelor und Prasugrel in diesem Patientenkollektiv mittels Vollblut-Impedanz-Aggregometrie im Multiplate Analyzer zu messen. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Investigation of the genetic status with regard to the existence of the CYP2C19*2 allele |
Untersuchung des genetischen Status in Bezug auf das Vorhandensein des CYP2C19*2 Allels |
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E.3 | Principal inclusion criteria |
- patients after coronary intervention
- insufficient inhibition of platelet aggregation after Clopidogrel loading
- informed, written consent |
- Patienten nach Koronarintervention
- Unzureichende Thrombozytenaggregationshemmung nach Clopidogrel loading
- schriftliche Einverständniserklärung
|
|
E.4 | Principal exclusion criteria |
- age < 18 years >, > 80 years
- body weight < 60 kg
- surgical intervention < 6 weeks
- apoplexy in anamnesis
- cardiogenic shock
- oral anticoagulation
- GPIIb/IIIa antagonists < 10 days or periprocedural
- platelet count < 100.000/µl
- increased risk for bradycardia
- severe liver dysfunction
- dialysis-dependent renal insufficiency
- simultaneous taking of CYP3A4 inhibitors |
- Alter <18 Jahre, > 80 Jahre
- Körpergewicht < 60 kg
- Operativer Eingriff vor < 6 Wochen
- Apoplex in der Anamnese
- Kardiogener Schock
- Orale Antikoagulation
- GPIIb/IIIa Antagonisten < 10 Tage oder periprozedural
- Thrombozytenzahl < 100.000/µl
- Erhöhtes Risiko für Bradykardien
- schwere Leberfunktionsstörung
- dialysepflichtige Niereninsuffizienz
- gleichzeitige Einnahme von CYP3A4 Inhibitoren
|
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E.5 End points |
E.5.1 | Primary end point(s) |
ADP-induced platelet aggregation on 2nd. day after randomization |
ADP-induzierte Thrombozytenaggregation am Tag 2 nach Randomisierung |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 2 after randomization |
Tag 2 nach Randomisierung |
|
E.5.2 | Secondary end point(s) |
- (1)portion of patients with insufficient inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off > 468 AU*min) on the 2nd. day after randomization
- (2)portion of patients with exceeding inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off < 188 AU*min) on the 2nd. day after randomization
- (3)ADP-induced platelet aggregation, point in time: 2 weeks after randomization during Ticagrelor or Prasugrel maintenance therapy |
- (1)Anteil der Patienten mit insuffizienter Hemmung der Thrombozytenaggregation in der Ticagrelor oder in der Prasugrel Gruppe (cut-off > 468 AU*min) am Tag 2 nach Randomisierung
- (2)Anteil der Patienten mit übermäßiger Thrombozytenaggregations-hemmung in der Ticagrelor oder in der Prasugrel Gruppe (cut-off < 188 AU*min) am Tag 2 nach Randomisierung
- (3)ADP-induzierte Thrombozytenaggregation 2 Wochen nach Randomisierung unter Ticagrelor oder Prasugrel Erhaltungstherapie |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- concerning points (1) and (2): day 2 after randomization
- concerning point (3): 2 weeks after randomization |
- für die Punkte (1) und (2): Tag 2 nach Randomisierung
- für den Punkt (3): 2 Wochen nach Randomisierung |
|
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 | 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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 |
letztes Follow-up des zuletzt in die Studie aufgenommenen Patienten |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |