Ignite Creation Date:
2024-05-06 @ 2:04 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01961856
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2013-10-09
Brief Title:
Ticagrelor Loading Dose Versus Clopidogrel Loading and Reloading With Ticagrelor
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
Official Title:
Platelet Reactivity After Ticagrelor Loading Dose Versus Clopidogrel Loading Dose and Reloading With Ticagrelor in Patients With ST-elevation Myocardial Infarction STEMI Undergoing Primary Percutaneous Coronary Intervention PCI
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the PLATO substudy referring to patients presenting with an ST-elevation Myocardial InfarctionSTEMI out of the 4201 who received ticagrelor 1326 had been pre-treated with a 600mg clopidogrel loading dose LD within 24 hours prior to randomization It is a logical assumption that patients who are being reloaded with ticagrelor will demonstrate reduced platelet reactivity PR at 24 hours in comparison to those who were initially loaded with ticagrelor due to the synergistic antiplatelet effect Single loading with ticagrelor though will possibly be accompanied by a smaller bleeding potency compared to reloading with ticagrelor Therefore we assume that single loading with ticagrelor is non-inferior to reloading with ticagrelor in terms of platelet reactivity
P2Y12 inhibitor naive patients with STEMI they will be randomized immediately after coronary angiography Hour 0 in receiving either Ticagrelor 180mg LD or Clopidogrel 600mg LD and 2 hours later reloading with Ticagrelor 180mg after written informed consent PR will be measured using the VerifyNow assay at randomization Hour 0 and at 2 4 6 and 24 hours post randomization In addition a 12-lead ECG will be performed before randomization 90 and 180 minutes after the first balloon inflation as well as on the exit day Troponin I and CK-MB will be assessed at randomization and at hour 4 12 24 48 and 72 after randomization
Non inferiority of Ticagrelor LD versus Ticagrelor re-LD would be accepted if the upper bound of the 2-sided 95 CI around the estimated LS mean difference Ticagrelor LD minus Ticagrelor re-LD in the primary end point PR at 24 hours would lie bellow Δ35 PRU This non-inferiority margin Δ represents the upper bound of the LS mean difference in PR between Ticagrelor and Prasugrel arm at 24 hours after LD in a pharmacodynamic study of 55 STEMI patients
Considering previous studies PR at 24 hours post randomization was estimated at 4740 PRU and 4135 PRU for Ticagrelor only LD and Ticagrelor re-LD group respectively To obtain 85 statistical power with a 2-sided alpha005 approximately 32 patients in each treatment group 64 in total would be needed to establish the primary hypothesis using the abovementioned non-inferiority margin of 35 PRU Anticipating a 5 dropout rate enrollment was set to at least 68 patients The primary endpoint as well as PR at all the other time points of the study will be analyzed separately via a mixed effect model with treatment as fixed effect patient as a random intercept and PR at baseline as a covariate Least squares estimates of the mean difference will be presented with 95 confidence intervals and a two-sided p-value for the treatment effect P values for secondary endpoints will be reported for two-tailed tests of superiority
P2Y12 inhibitor naive patients with STEMI they will be randomized immediately after coronary angiography Hour 0 in receiving either Ticagrelor 180mg LD or Clopidogrel 600mg LD and 2 hours later reloading with Ticagrelor 180mg after written informed consent PR will be measured using the VerifyNow assay at randomization Hour 0 and at 2 4 6 and 24 hours post randomization In addition a 12-lead ECG will be performed before randomization 90 and 180 minutes after the first balloon inflation as well as on the exit day Troponin I and CK-MB will be assessed at randomization and at hour 4 12 24 48 and 72 after randomization
Non inferiority of Ticagrelor LD versus Ticagrelor re-LD would be accepted if the upper bound of the 2-sided 95 CI around the estimated LS mean difference Ticagrelor LD minus Ticagrelor re-LD in the primary end point PR at 24 hours would lie bellow Δ35 PRU This non-inferiority margin Δ represents the upper bound of the LS mean difference in PR between Ticagrelor and Prasugrel arm at 24 hours after LD in a pharmacodynamic study of 55 STEMI patients
Considering previous studies PR at 24 hours post randomization was estimated at 4740 PRU and 4135 PRU for Ticagrelor only LD and Ticagrelor re-LD group respectively To obtain 85 statistical power with a 2-sided alpha005 approximately 32 patients in each treatment group 64 in total would be needed to establish the primary hypothesis using the abovementioned non-inferiority margin of 35 PRU Anticipating a 5 dropout rate enrollment was set to at least 68 patients The primary endpoint as well as PR at all the other time points of the study will be analyzed separately via a mixed effect model with treatment as fixed effect patient as a random intercept and PR at baseline as a covariate Least squares estimates of the mean difference will be presented with 95 confidence intervals and a two-sided p-value for the treatment effect P values for secondary endpoints will be reported for two-tailed tests of superiority
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None