ComparisoN of ticAgrelor vs. Clopidogrel in endoTHeliAl Function of COPD patieNts (NATHAN-NEVER)
Coronary Artery Disease, Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring chronic obstructive pulmonary disease, stable coronary artery disease, ticagrelor, clopidogrel, endothelial function, inflammation, platelet reactivity
Eligibility Criteria
Type of Patients Subjects either male or female eligible for PCI and undergoing drug eluting stent implantation who have meet all inclusion criteria and did not meet any of the exclusion criteria.
Inclusion Criteria:
For inclusion in the study subjects should fulfill the following criteria:
- Age ≥18 years;
- Ability to provide informed written consent and to participate in the 6-months follow-up period;
- Diagnosis of SCAD requiring coronary artery angiography
- COPD diagnosis confirmed by spirometry in stable phase and after medical treatment from at least 3 months.
Exclusion Criteria:
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Patients hospitalized with diagnosis of acute coronary syndrome
- Previous chronic use of P2Y12 inhibitors
- Known intolerance to aspirin and/or P2Y12 inhibitors
- Absence of significant variation in guideline driven medical treatment in the last 15 days
- History of intracranial haemorrhage
- Known intake of a strong CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir),
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period
- Planned surgery, including CABG as a staged procedure (hybrid) within 6 months;
- Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
- Need for chronic oral anti-coagulation therapy;
- Active major bleeding or major surgery within the last 30 days;
- Known stroke (any type) within the last 30 days;
- Currently participating in another trial before reaching primary endpoint;
- Thrombocytopenia;
- Increased risk of bradycardia;
- Known other inflammatory chronic disorders;
- Known or suspected malignancy
- Other concomitant pulmonary diseases
Sites / Locations
- University Hospital of Ferrara
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Aspirin 100 mg + Clopidogrel 75 mg
Aspirin 100 mg + Ticagrelor 90 mg x2
dual antiplatelet therapy as suggested by guidelines with aspirin 100 mg and clopidogrel 75 mg daily
dual antiplatelet therapy with aspirin 100 mg and ticagrelor 90 mg x 2 daily