Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome

NCT04567290 | Unknown Phase 4

• 1 other identifier: 12345
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention

Conditions

Acute Coronary Syndrome

Keywords

Ticagrelor; Platelet aggregation inhibitors; VerifyNow; Acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity

  Platelet reactivity measured with VerifyNow (PRU)

  1 hour

Secondary Outcomes (4)

• Efficacy (MACCE)

  30 days

• Composite outcome

  30 days

• Efficacy (long term)

  1 year

• High platelet reactivity on treatment rate

  1 hour

Study Arms (2)

Chewed ticagrelor

EXPERIMENTAL

Ticagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff. Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed

Drug: Chewed ticagrelor

Swallowed ticagrelor

ACTIVE COMPARATOR

Ticagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water. Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed

Drug: Swallowed ticagrelor

Interventions

Chewed ticagrelor DRUG

Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets

Chewed ticagrelor

Swallowed ticagrelor DRUG

Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets

Swallowed ticagrelor

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention

You may not qualify if:

• Age \<18 years
• Known coagulopathy, bleeding diathesis, or active bleeding
• History of recent gastrointestinal or genitourinary bleeding within 2 months
• Previous therapy with clopidogrel, prasugrel, or ticagrelor
• Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure
• Major surgery within 6 weeks
• History of intracranial bleeding or intracraneal neoplasm
• Suspected aortic dissection
• Chronic obstructive pulmonary disease
• Severe hemodynamic instability or cardiogenic shock
• Resuscitated cardiac arrest
• Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days
• Life expectancy \<1 year
• Known severe liver or renal disease, GFR estimated by CKD-EPI \<30 ml/min/1.73 m2
• Known HIV treatment

Sponsors & Collaborators

• Centro Hospitalario La Concepcion: lead

Study Sites (1)

Hospital La Concepción

Saltillo, Coahuila, Mexico

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Carlos Felipe Barrera Ramírez, MD

CONTACT

8441602269; carlosfbarrera@yahoo.com

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: September 21, 2020
• First Posted: September 28, 2020
• Study Start: October 7, 2020
• Primary Completion: August 15, 2021
• Study Completion: September 30, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)