Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01433627
Status:
UNKNOWN
Last Update Posted:
2015-01-29
First Post:
2011-09-12
Brief Title:
Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX
Sponsor:
Italian Society of Invasive Cardiology
Organization:
Italian Society of Invasive Cardiology
Study Overview
Official Title:
Phase IIIb Study Minimizing Adverse Haemmhorragic Events by TRansradial Access Site and Systemic Implementation of angioX MATRIX
Status:
UNKNOWN
Status Verified Date:
2015-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
MATRIX
Brief Summary:
This protocol describes a study to compare intended trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated heparin UFH plus provisional use of glycoprotein IIbIIIa inhibition via the use of one of the three available agents on the market eg abciximab tirofiban or eptifibatide in patients 18 years with ACS that are intended for an invasive management strategy This study will be conducted in compliance with Good Clinical Practices GCP including the Declaration of Helsinki and all applicable regulatory requirements
Detailed Description:
The use of combined antithrombotic therapies over the last two decades has decreased the risk of a heart attack after percutaneous coronary intervention substantially but has also been associated with a significant increase in bleeding risk Therapies or strategies that maintain the benefits seen with currently available antithrombotic therapies but which have lower bleeding risk are therefore of great clinical importance Indeed major bleeding is currently the most common non-cardiac complication of therapy for patients with coronary artery disease who have undergone percutaneous coronary intervention PCI
Bleeding in patients with acute coronary syndrome ACS is associated with an increased risk of long term mortality and morbidity and this relationship is currently thought to be causal Therefore reducing the frequency of bleeding events while maintaining efficacy is an important goal in the management of patients with ACS The most common site of bleeding in invasively managed patients with ACS is at the femoral artery puncture site used for heart catheterization
The MATRIX study is a multi-centre prospective randomised open-label 2 by 2 factorial comparison of trans-radial vs trans-femoral intervention and bivalirudin vs unfractionated heparin and provisional use of glycoprotein IIbIIIa inhibitor
Objectives
1 To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management
2 To demonstrate that bivalirudin infusion as compared to standard of care therapy consisting of unfractionated heparin and provisional use of glycoprotein IIbIIIa inhibitors are associated to lower rate of the composite endpoint of death MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management
Patients randomly assigned to receive bivalirudin will be randomized to stop bivalirudin infusion at the end of PCI or to prolong bivalirudin at an infusion rate of 025 mgkghour for at least 6 hours after completion of PCI The primary hypothesis in this sub-randomization is that prolonged post-intervention bivalirudin infusion will be superior to no bivalirudin post-PCI infusion with respect to the net composite outcome consisting of any death MI stroke urgent TVR stent thrombosis and BARC-defined type 3 and 5 bleeding events within 30 days Secondary objectives for the sub-randomization of prolonged bivalirudin versus no post-PCI infusion in the bivalirudin group will consist of each component of the primary composite endpoint through the entire follow-up duration
Bleeding in patients with acute coronary syndrome ACS is associated with an increased risk of long term mortality and morbidity and this relationship is currently thought to be causal Therefore reducing the frequency of bleeding events while maintaining efficacy is an important goal in the management of patients with ACS The most common site of bleeding in invasively managed patients with ACS is at the femoral artery puncture site used for heart catheterization
The MATRIX study is a multi-centre prospective randomised open-label 2 by 2 factorial comparison of trans-radial vs trans-femoral intervention and bivalirudin vs unfractionated heparin and provisional use of glycoprotein IIbIIIa inhibitor
Objectives
1 To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management
2 To demonstrate that bivalirudin infusion as compared to standard of care therapy consisting of unfractionated heparin and provisional use of glycoprotein IIbIIIa inhibitors are associated to lower rate of the composite endpoint of death MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management
Patients randomly assigned to receive bivalirudin will be randomized to stop bivalirudin infusion at the end of PCI or to prolong bivalirudin at an infusion rate of 025 mgkghour for at least 6 hours after completion of PCI The primary hypothesis in this sub-randomization is that prolonged post-intervention bivalirudin infusion will be superior to no bivalirudin post-PCI infusion with respect to the net composite outcome consisting of any death MI stroke urgent TVR stent thrombosis and BARC-defined type 3 and 5 bleeding events within 30 days Secondary objectives for the sub-randomization of prolonged bivalirudin versus no post-PCI infusion in the bivalirudin group will consist of each component of the primary composite endpoint through the entire follow-up duration
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-000430-11 | EUDRACT_NUMBER | None | None |