Research on treatment strategies for adequate anitplatelet therapy for the prevention of major cardiac events after vascular surgery

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; myocardial injury in patients undergoing major vascular surgery, leading to (spontaneous) acute coronary syndrome and death through intracoronary plaque damage and subsequent thrombosis after major vascular surgery.

• Registration Number: EUCTR2016-000686-23-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Preoperative myocardial injury (baseline value), defined as hsTnT release > 14 ng/L.
2.Absence of significant occlusive coronary artery disease as diagnosed through angiography (and confirmed by FFR).
3.Postoperative myocardial injury, defined as hsTnT release > 14 ng/L, which exceed the baseline value.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. if troponin elevation is diagnosed as myocardial infarction by cardiologist.
2. Presence of significant occlusive coronary artery disease, as diagnosed through preoperative angiography, requiring treatment.
3.No postoperative hsTnT values above the clinical reference of 14 ng/L and no rise with respect to baseline value.
4.Active bleeding.
5.Active cardiac conditions at the time of randomisation such as unstable angina pectoris, active congestive heart failure (CHF), serious cardiac arrhythmias, symptomatic valvular disease.
6.Clear indication for long-term P2Y12 inhibitor use.
7.Preoperative use of P2Y12 inhibitors.
8.Previous allergy or intolerance to clopidogrel.
9.Use of oral anticoagulants after surgery.
10.Use of intravenous glycoprotein IIB/IIA receptor inhibitors in the previous three days.
11.Coronary revascularization therapy in the previous six months.
12.Renal failure requiring dialysis.
13.Significant liver disease (i.e. ALAT, ASAT > 3x ULN).
14.Cancer with an expected life expectancy less than 6 months.
15.Excessive alcohol use.
16.No informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified