Chewed Versus Integral Pill of Ticagrelor

NCT03708588 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-078_18-911
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.

Conditions

Percutaneous Coronary Intervention

Keywords

Ticagrelor; Stent

Outcome Measures

Primary Outcomes (1)

• Concentration of Pharmacodynamics

  Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.

  1 hour

Secondary Outcomes (2)

• Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)

  30 days

• Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)

  1 year

Study Arms (2)

Experimental: Chewed ticagrelor

EXPERIMENTAL

Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)

Drug: Ticagrelor

Active Comparator: Integral pill

ACTIVE COMPARATOR

Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL (milliliter) of water. (180mg)

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Chewed

Also known as: Brilinta, Brilique, Possia

Experimental: Chewed ticagrelor

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.

You may not qualify if:

• Age \<18 years or Age \>89 years
• Known coagulopathy, bleeding diathesis, or active bleeding
• History of recent gastrointestinal or genitourinary bleed within 2 months
• Known chronic therapy with clopidogrel, prasugrel, or ticagrelor
• Major surgery within last 6 weeks
• History of intracranial bleed or intracranial neoplasm
• Suspected aortic dissection
• Severe hemodynamic instability, cardiogenic shock
• Life expectancy \<1 year
• Known severe liver or renal disease
• Known HIV treatment
• Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure
• Any use of Cangrelor during or after the procedure
• Hemoglobin \<10 g/dL, platelet (PLT) \<100x10\^9/L
• Pregnancy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Health Care, St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Study limitations include the relatively small sample size, single-center design, and lack of pharmacokinetic confirmation of platelet reactivity.

Results Point of Contact

• Title: Suhail Allaqaband, MD
• Organization: Aurora Health Care

suhail.allaqaban@aah.org

414-469-3491

Study Officials

• Suhail Allaqaband, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 17, 2018
• Study Start: September 19, 2018
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: October 3, 2024
• Results First Posted: January 18, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)