A Clinical Trial for the comparison of Ticagrelor and Clopidogrel in Patients with CoronarY Artery Disease.

Phase 1

• Conditions: Coronary Artery Disease (with an indication for coronary angiography); MedDRA version: 14.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004376-35-GR
• Lead Sponsor: Hellenic Cardiovascular Research Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Provision of informed consent prior to any study specific procedures.
-?ale and female subjects > 18 and < 79 years of age.
- Indication for elective coronary angiography (angina, positive stress test/SPECT/stress echo) with or without PCI for inclusion in the ‘acute’ study period, and indication for either ad hoc or elective PCI for inclusion in the ‘chronic’ study period.

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Subjects who had ACS within 12 months of screening.
2.Previous stent implantation with dual antiplatelet therapy within 12 months of screening.
3.Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
4.Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
5.Subjects with hemodynamic or electrical instability (including shock).
6.History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
7.Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
8.Any previous history of ischemic or hemorrhagic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
9.International Normalized Ratio (INR) known to be >1.5 within 1 week of study entry.
10.Poorly controlled blood pressure (>160/100 mmHg).
11.Known platelet count of <100,000/mm3 within 1 week of study entry.
12.Known anemia (hemoglobin [Hb] <10 gr/dL) within 1 week of study entry.
13.Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
14.Severe kidney disease (GFR<30 ml/min/1.73m2).
15.Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia defined as peak total serum bilirubin greater than 2 times the upper limit of normal (ULN).
16.Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, pulmonary embolism (PE), deep vein thrombosis (DVT)) for anticoagulation treatment during study period.
17.Asthma or chronic obstructive pulmonary disease requiring brochodilating agents.
18.Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
19.Concomitant use of drugs that are metabolized through CYP2C19 (omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol).
20.History of uric acid nephropathy and high levels of uric acid within 1 week of study entry.
21.Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
22.Known neoplastic or autoimmune disease or any concomitant medical illness that in the opinion of the Investigator may interfere with or prevent completion in this study.
23.Contraindication to clopidogrel, ASA, or ticagrelor.
24.A history of alcohol and/or substance abuse that could interfere with conduct of the trial.
25.Pregnancy or lactation

Study & Design

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