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

NCT02626169 | Withdrawn Phase 4

• 1 other identifier: H-33860
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atherosclerosis

Keywords

15-epi-lipoxin A4; inflammation; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Plasma levels of 15-epi-lipoxin A4

  Percent change in plasma levels of 15-epi-lipoxin A4 from baseline (%)

  30 days

Secondary Outcomes (2)

• Plasma levels of C Reactive Protein (CRP)

  30 days

• platelet aggregation in blood sample

  30 days

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75 mg once a day by mouth for 30 days

Drug: Clopidogrel

Ticagrelor

ACTIVE COMPARATOR

Ticagrelor 90 mg twice daily by mouth for 30 days

Drug: Ticagrelor

Interventions

Clopidogrel DRUG

Clopidogrel 75 mg once a day by mouth for 30 days

Also known as: Plavix

Clopidogrel

Ticagrelor DRUG

Ticagrelor 90 mg twice daily by mouth for 30 days

Also known as: Brilinta

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor Clinic

Houston, Texas, 77030, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Inflammation

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Yochai Birnbaum, MD

  Baylor College of Medicine, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)