Monitoring the effect of blood thinners during percutaneous coronary interventio

Phase 1

• Conditions: Anticoagulation during percutaneous coronary intervention; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005298-29-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-13
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patient must meet all of the following criteria:
-Male or female = 18 years
-Undergoing elective PCI
-Loaded with P2Y12 inhibitors before PCI
-Patients with signed informed consent

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 100

Exclusion Criteria

Patients who fulfill the above mentioned inclusion criteria but who manifest any of the following exclusion criteria will not be eligible for the study:
-Patients with hematologic, renal (estimated glomerular filtration rate <45 ml/min/1.73m2), hepatic (liver enzymes >2 times the upper limit of normal), inflammatory (CRP >2 times the upper limit of normal) or neoplastic disorders
-Patients using nonsteroidal anti-inflammatory drugs, corticosteroids, or hormone replacement therapy

Study & Design

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