Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX)

Phase 3

Completed

• Conditions: Myocardial infarction; unstable angina with rest complaints; 10011082

• Registration Number: NL-OMON40840
• Lead Sponsor: Società Italian di Cardiologia Invasiva GISE

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-12
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

1. history consistent with new, or worsening ischemia, occurring at rest or with minimal activity;
2. enrolment within 7 days of the most recent symptoms;
3. planned coronary angiography with possible indication to PCI;
4. at least 2 of the following criteria:
• Aged 60 years or older,
• Troponin T or I or creatine kinase MB above the upper limit of normal;
• Electrocardiograph changes compatible with ischemia, ie, ST depression of 1 mm or greater in 2 contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts.

Exclusion Criteria

1. Patients who can not give informed consent or have a life expectancy of <30 days.
2. Allergy/intolerance to bivalirudin or unfractionated heparin.
3. Stable or silent CAD as indication to coronary angiography.
4. Treatment with LWMH within the past 6 hours.
5. Treatment with any GPI in the previous 3 days.
6. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including both aspirin and clopidogrel.
7. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
8. If it is known, pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
9. If it is known, a creatinine clearance <30 mL/min or dialysis dependent.
10. Previous enrolment in this study.
11. Treatment with other investigational drugs or devices within the preceding 30 days.
12. Randomisation or planned use of other investigational drugs or devices in this trial.
13. Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment).
14. Subacute bacterial endocarditis.
15. PCI in the previous 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint at 30 days:<br /><br>• A composite of death, re-infarction (MI) or stroke</p><br>