acute ST-segment elevation myocardial infarction (STEMI) with large coronary thrombus burden (LCTB).
Conditions
Interventions
Product Name: RIVAROXABAN
Product Code: [B01AF01]
Pharmaceutical Form: Tablet
Current Sponsor code: B01AF01
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trad
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of acute STEMI with a large thrombotic burden Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: -Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding -Cardiogenic shock at presentation or life-threatening electrical instability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The reduction of thrombus burden and thrombus volume, measured as the difference of Thrombotic Score between baseline and control at OCT. The control angiography and OCT will be performed between day 5 th and 7 th . The primary coagulation-related of the study is the factor XIa activity at baseline and after 4-7 days of treatments;Secondary Objective: Coagulation cascade factors activity at presentation and after 4-7 days Factor Xa and IIa (common pathway) Factor XIa and VIIIa (intrinsic pathway) Factor VIIa (extrinsic pathway) Angiographic outcomes before stenting implantation: White vs. red thrombus presence Angiographic outcomes after stenting implantation: Final TIMI flow; Final TIMI frame count; Final myocardial blush grade; Clinical outcomes at 30 days: - The percentage of patients with MACE (composite of all cause death, myocardial infarction, stroke or new target vessel revascularization) - The percentage of patients with major bleeding - The percentage of patients with any bleeding Safety outcome at 30 days: the rate of major bleedings at 30-day;Primary end point(s): The reduction of thrombus burden and thrombus volume, measured as the difference of Thrombotic Score between baseline and control at OCT. The control angiography and OCT will be performed between day 5 th and 7 th . The primary coagulation-related of the study is the factor XIa activity at baseline and after 4-7 days of treatments;Timepoint(s) of evaluation of this end point: 4-7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Coagulation cascade factors activity at presentation and after 4-7 days Factor Xa and IIa (common pathway) Factor XIa and VIIIa (intrinsic pathway) Factor VIIa (extrinsic pathway) Angiographic outcomes before stenting implantation: White vs. red thrombus presence Angiographic outcomes after stenting implantation: Final TIMI flow; Final TIMI frame count; Final myocardial blush grade; Clinical outcomes at 30 days: - The percentage of patients with MACE (composite of all cause death, myocardial infarction, stroke or new target vessel revascularization) - The percentage of patients with major bleeding - The percentage of patients with any bleeding Safety outcome at 30 days: the rate of major bleedings at 30-day;Timepoint(s) of evaluation of this end point: 7 and 30 days | — |
Countries
Italy
Contacts
Public ContactMarco Mennuni
AOU Maggiore della Carità
Outcome results
None listed