Acute ST Segment Elevation Myocardial Infarction Clinical Trial
Official title:
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.
MASTER is prospective, randomized (3:1), single blind, controlled, superiority (efficacy) and
non-inferiority (safety and efficacy), multi center, two-arm trial of TCD-10023 (Ultimaster)
drug eluting stent (test) and Kaname bare metal stent (comparator).
Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 3
years.
500 patients with clinical follow up will be randomized in 3:1 ratio (375 in TCD-10023 arm
and 125 in Kaname arm). Among them, 100 patients will be randomized in the same, 3:1 ratio,
to angiographic follow up at 6 months in preselected hospitals (75 in TCD-10023 and 25 in
Kaname arm)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06435728 -
Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
|
||
| Completed |
NCT02914795 -
Platelet Function in Resuscitated Patients
|
||
| Recruiting |
NCT00697021 -
Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance
|
Phase 3 | |
| Completed |
NCT05949515 -
Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
|
||
| Completed |
NCT01986803 -
ABSORB STEMI: the TROFI II Study
|
N/A | |
| Active, not recruiting |
NCT01878344 -
Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention
|
Phase 3 | |
| Withdrawn |
NCT02048085 -
Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis
|
Phase 4 | |
| Completed |
NCT04463251 -
Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction
|
Phase 2 | |
| Active, not recruiting |
NCT02943954 -
FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction
|
N/A | |
| Completed |
NCT02298088 -
Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis
|
Phase 3 | |
| Active, not recruiting |
NCT02067091 -
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct
|
Phase 3 | |
| Completed |
NCT01787110 -
An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction
|
Phase 3 | |
| Recruiting |
NCT03137212 -
Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time
|
N/A | |
| Not yet recruiting |
NCT05802667 -
A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
|
||
| Completed |
NCT04730778 -
Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
|