Study of anti-clotting medications in patients undergoing stent treatment for coronary artery disease

Phase 1

• Conditions: Coronary Artery Disease; MedDRA version: 17.1 Level: PT Classification code 10052086 Term: Coronary arterial stent insertion System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004783-38-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures.
2. Male or female aged greater than 18 years.
3. Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Requirement for a chronic total occlusion to be crossed in order for any stent implantation to proceed.
2. Plan for coronary angiography with a view to PCI if appropriate (i.e. current coronary anatomy not known).
3. Intention to use platelet function tests or genotyping to guide antiplatelet therapy.
4. Known allergy to or intolerance of aspirin, clopidogrel or ticagrelor.
5. Treatment with antiplatelet medication apart from aspirin or clopidogrel that cannot be stopped 10 days prior to PCI (e.g. ticagrelor, prasugrel, dipyridamole, ticlopidine, abciximab, tirofiban), for example because of continuing indication.
6. Planned treatment or consideration of treatment with oral antiplatelet medication other than aspirin or clopidogrel following PCI.
7. Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.
8. Myocardial infarction within the past 12 months.
9. Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban).
10. Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk.
11. Haemoglobin < 100 g/L or other evidence of active bleeding.
12. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy.
13. History of acute or chronic liver disease (e.g. cirrhosis).
14. Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer.
15. Requirement for ongoing treatment with simvastatin or lovastatin at a dose greater than 40 mg per day.
16. Treatment with a CYP3A4 substrate with a narrow therapeutic index (e.g. cyclosporine, quinidine).
17. End-stage renal failure requiring dialysis.
18. History of alcohol or drug abuse in the last year.
19. Co-morbidity associated with life expectancy less than 1 year.
20. Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication.
21. Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor.

Study & Design

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