Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02293395
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2014-11-13
Brief Title:
A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Double-Dummy Active-controlled Parallel-group Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2017-11
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:
GEMINI ACS 1
Brief Summary:
The purpose of this study is to estimate the risk of bleeding with rivaroxaban compared with acetylsalicylic acid ASA in addition to a single antiplatelet platelet adenosine diphosphate P2Y12 receptor antagonist P2Y12 inhibitor agent clopidogrel or ticagrelor in participants with a recent acute coronary syndrome ACS including ST segment elevation myocardial infarction STEMI and non-ST-segment elevation acute coronary syndrome NSTE-ACS
Detailed Description:
This is a prospective randomized the study drug is assigned by chance double-blind neither physician nor participant knows the treatment that the participant receives active-controlled study in which the experimental treatment or procedure is compared to a standard treatment or procedure parallel group each group of participants will be treated at the same time multicenter when more than one hospital or medical school team work on a medical research study study in participants with a recent ACS STEMI or NSTE-ACS All the eligible participants receiving background treatment of ASA plus clopidogrel Stratum 1 or ASA plus ticagrelor Stratum 2 will be randomly assigned to either receive ASA or rivaroxaban on background of P2Y12 receptor antagonists treatment This study will include 3 phases Screening Phase up to 10 days before study start on Day 1 Double-blind Treatment Phase up to either 180 days after randomization of the last enrolled participant in the study or Day 360 whichever occurs earlier and Follow-up Phase up to 30 days Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004266-26 | EUDRACT_NUMBER | Janssen Research Development LLC | None |
| RIVAROXACS2002 | OTHER | None | None |