- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00357968
Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting (PRINCIPLE)
Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Lille, Francja, 59037
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marseille, Francja, 13385
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris, Francja, 75013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tours, Francja, 37044
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Haifa, Izrael, 31096
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jerusalem, Izrael, 91120
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tel Hashomer, Izrael, 52621
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bad Krozingen, Niemcy, D-79189
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Berlin, Niemcy, D-12203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Giessen, Niemcy, 35392
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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München, Niemcy, D-80636
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tubingen, Niemcy, 72076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32209
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Worcester, Massachusetts, Stany Zjednoczone, 01655
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Dakota
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Rapid City, South Dakota, Stany Zjednoczone, 57701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
At least one of the following (a through c):
Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
- A reversible defect on nuclear imaging.
- A reversible wall-motion abnormality by echocardiography.
- Horizontal or down-sloping ST-depressions greater than 1 mm on electrocardiogram (ECG) (if no imaging performed).
- Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
- A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment.
Exclusion Criteria:
- Known creatine kinase-myocardial bands (CK-MB)or cardiac troponin greater than the upper limit of normal at time of screening
- Planned PCI for acute myocardial infarction (MI) or planned PCI within 48 hours of fibrinolytic therapy for ST segment elevation myocardial infarction (STEMI)
- Have cardiogenic shock at the time of screening (systolic blood pressure 90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
- Refractory ventricular arrhythmias
- Have New York Heart Association Class IV congestive heart failure
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Prasugrel to Clopidogrel
One time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days.
Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days.
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Podawany doustnie
Inne nazwy:
Administered orally
Administered orally
Administered orally
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Aktywny komparator: Clopidogrel to Prasugrel
One time oral LD of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for 14 days.
Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days.
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Podawany doustnie
Inne nazwy:
Administered orally
Administered orally
Administered orally
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose
Ramy czasowe: 6 hours after loading dose
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IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.
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6 hours after loading dose
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Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment
Ramy czasowe: after 14 days of maintenance dosing
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Measures IPA during maintenance dosing before and after cross-over for each therapy. IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100. |
after 14 days of maintenance dosing
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose
Ramy czasowe: 2 hours after loading dose
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IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.
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2 hours after loading dose
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Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase
Ramy czasowe: after 14 days of treatment (before cross-over)
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Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL. |
after 14 days of treatment (before cross-over)
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Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase
Ramy czasowe: 14 days after cross-over
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Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL. |
14 days after cross-over
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Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase
Ramy czasowe: after 14 days of treatment (before cross-over)
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Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
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after 14 days of treatment (before cross-over)
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Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase
Ramy czasowe: 14 days after cross-over
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Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
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14 days after cross-over
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Number of Hyporesponsive Participants at 6 Hours After the Loading Dose
Ramy czasowe: 6 hours after loading dose
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Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
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6 hours after loading dose
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Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase
Ramy czasowe: From loading dose to day 15
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Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
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From loading dose to day 15
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Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase
Ramy czasowe: 14 days after cross-over
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Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
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14 days after cross-over
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose
Ramy czasowe: 2 hours after loading dose
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index.
A lower PRI indicates greater antiplatelet effect.
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2 hours after loading dose
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose
Ramy czasowe: 6 hours after loading dose
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index.
A lower PRI indicates greater antiplatelet effect.
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6 hours after loading dose
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose
Ramy czasowe: 18 to 24 hours after loading dose
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index.
A lower PRI indicates greater antiplatelet effect.
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18 to 24 hours after loading dose
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment
Ramy czasowe: after 14 days of maintenance dosing
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index.
A lower PRI indicates greater antiplatelet effect.
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after 14 days of maintenance dosing
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Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose
Ramy czasowe: 6 hours after loading dose
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Mean CK-MB at 6 hours after loading dose.
CK-MB is a biomarker for myonecrosis
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6 hours after loading dose
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Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose
Ramy czasowe: 18 to 24 hours after loading dose
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Mean CK-MB at 18-24 hours after loading dose.
CK-MB is a biomarker for myonecrosis.
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18 to 24 hours after loading dose
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Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose
Ramy czasowe: 6 hours after loading dose
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Mean troponin level at 6 hours after the loading dose.
Troponin is a biomarker for myonecrosis.
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6 hours after loading dose
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Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose
Ramy czasowe: 18 to 24 hours after loading dose
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Mean troponin level at 18 to 24 hours after the loading dose.
Troponin is a biomarker for myonecrosis.
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18 to 24 hours after loading dose
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Niedokrwienie mięśnia sercowego
- Choroby serca
- Choroby układu krążenia
- Choroby naczyniowe
- Arterioskleroza
- Choroby okluzyjne tętnic
- Choroba wieńcowa
- Choroba wieńcowa
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory agregacji płytek krwi
- Antagoniści receptora purynergicznego P2Y
- Antagoniści receptora purynergicznego P2
- Antagonistów purynergicznych
- Środki purynergiczne
- Klopidogrel
- Chlorowodorek prasugrelu
Inne numery identyfikacyjne badania
- 10635
- H7T-MC-TABL (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Choroba wieńcowa
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Bambino Gesù Hospital and Research InstituteZakończonyCiężka otyłość dziecięca (BMI > 97° szt. -według wykresów BMI Centers for Disease Control and Prevention-) | Zmienione testy czynnościowe wątroby | Nietolerancja glikemicznaWłochy
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Spero TherapeuticsZakończonyKompleks Mycobacterium Avium | Niegruźlicze Mycobacterium Pulmonary DiseaseStany Zjednoczone
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Janssen Pharmaceutical K.K.RekrutacyjnyOporna na leczenie Mycobacterium Avium Complex-lung Disease (MAC-LD)Tajwan, Republika Korei, Japonia
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Adelphi Values LLCBlueprint Medicines CorporationZakończonyBiałaczka z komórek tucznych (MCL) | Agresywna mastocytoza układowa (ASM) | SM w Assoc Clonal Hema Lineage Non-mast Cell Lineage Disease (SM-AHNMD) | Tląca się mastocytoza układowa (SSM) | Indolentna układowa mastocytoza (ISM) Podgrupa ISM w pełni zatrudnionaStany Zjednoczone
Badania kliniczne na Prasugrel
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Eli Lilly and CompanyDaiichi Sankyo, Inc.Zakończony
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Taichung Veterans General HospitalZakończony
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Gyeongsang National University HospitalZakończonyKrwawienie | Ostry zespół wieńcowy | Zakrzep płytek krwiRepublika Korei
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University of FloridaZakończony
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University of MilanZakończony
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Medstar Health Research InstituteZakończonyOstry zespół wieńcowyStany Zjednoczone
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University of FloridaZakończony
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Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo CompanyZakończonyOstry zespół wieńcowy (ACS)Tajwan
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Rigshospitalet, DenmarkZakończonyZawał mięśnia sercowego z uniesieniem odcinka ST | Choroba niedokrwienna serca | Choroba sercaDania
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VA Office of Research and DevelopmentZakończonyObejście tętnicy wieńcowejStany Zjednoczone