Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity Study

NCT03016611 | Unknown Phase 4

• 1 other identifier: SHEBA-16-3634
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.

Conditions

Acute Coronary Syndrome; STEMI

Outcome Measures

Primary Outcomes (1)

• Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after Ticagrelor/Prasugrel LD

  1 hour

Secondary Outcomes (3)

• The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after Ticagrelor/Prasugrel LD

  4-6 hours

• Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events

  30 days

• Occurrence of dyspnea and/or symptomatic bradycardia

  30 days

Study Arms (2)

Chewing Ticagrelor

ACTIVE COMPARATOR

Drug: Chewing Prasugrel LD

Chewing Prasugrel

EXPERIMENTAL

Drug: Chewing Ticagrelor LD

Interventions

Chewing Ticagrelor LD DRUG

180 mg Chewing Ticagrelor

Chewing Prasugrel

Chewing Prasugrel LD DRUG

60 mg Chewing Prasugrel

Chewing Ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with STEMI
• Informed, written consent

You may not qualify if:

• Age \< 18 years or Age \> 75 years
• Active bleeding; bleeding diathesis; coagulopathy
• Increased risk of bradycardic events
• History of gastrointestinal or genitourinary bleeding \<2 months
• Major surgery in the last 6 weeks
• History of intracranial bleeding or structural abnormalities
• Suspected aortic dissection
• Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy \<1 year)
• Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
• Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
• Known relevant hematological deviations: Hb \<10 g/dl, PLT\<100x10\^9/l
• Use of coumadin derivatives within the last 7 days
• Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
• Known severe liver disease, severe renal failure
• Known allergy to the study medications

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Elad Asher, MD; MHA

CONTACT

+972-52-6667131; el.asher@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 10, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2017
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

IL (1)