The Effect of Ticagrelor on 15-Epi-Lipoxin A4 and Inflammation

Withdrawn before enrolling · Phase 4

Conditions studied: Atherosclerosis

In brief

Ticagrelor and clopidogrel are FDA-approved drugs for inhibition of platelet hyper-reactivity in certain clinical situations. The platelet inhibition and patient outcomes (PLATO) trial showed that in patients with acute coronary syndromes, ticagrelor significantly reduced the primary endpoint (cardiovascular death, myocardial infarction or stroke), all-cause mortality and cardiovascular mortality compared to clopidogrel. It has been suggested that in addition to its anti-platelet effects, ticagrelor has additional unique effects, including anti-inflammatory effects that are not shared by clopidogrel. In the present study the investigators will assess whether ticagrelor, as compared to clopidogrel, increases serum levels of 15-epi-lipoxin A4, a potent endogenous anti-inflammatory mediator.

Key facts

Study ID

NCT02626169

Run by

Baylor College of Medicine

People needed

0

Starts

2015-12-01

Expected to finish

2018-07-01

Last updated by the study team

2019-12-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of informed consent prior to any study specific procedures
• Women of childbearing potential must be using an acceptable method of contraception to avoid pregnancy throughout the study
• Patients with stable coronary artery disease (3-12 months after Acute Coronary Syndrome) who receive clopidogrel for at least 3 months.

You may not qualify if…

• Recent stroke or acute coronary syndromes (<3 months before randomization).
• Concurrent use of aspirin >100 mg/day where the dose reduction to 81 mg/day is contraindicated.
• Current use of theophylline.
• Concurrent use of Non Steroidal Anti-Inflammatory Drugs.
• Patients receiving the following medications: ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, telithromycin, rifampin, dexamethasone, phenytoin, carbamazepine, or phenobarbital. Patients receiving simvastatin or lovastatin at doses greater than 40 mg daily.
• Patients with type 2 diabetes with a fasting plasma glucose greater than 200 mg/dl.
• Active inflammatory disease or chronic infection.
• Contraindication for aspirin, clopidogrel or ticagrelor.
• Women who are pregnant or breastfeeding.

Where it is running

• Baylor Clinic — Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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