NCT02725099

Brief Summary

To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

March 27, 2016

Last Update Submit

January 9, 2017

Conditions

Acute Coronary SyndromesST Elevation Myocardial Infarction

Keywords

STEMI

Outcome Measures

Primary Outcomes (1)

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

    1, 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)

Oral Ticagrelor

ACTIVE COMPARATOR
Drug: Oral Ticagrelor

Chewing Ticagrelor

EXPERIMENTAL
Drug: Chewing Ticagrelor

Interventions

Chewing TicagrelorDRUG

180 mg Chewing Ticagrelor

Chewing Ticagrelor
Oral TicagrelorDRUG

180 mg oral Ticagrelor

Oral Ticagrelor

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 \> 90 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical center

Ramat Gan, Israel

Location

Related Publications (1)

  • Asher E, Tal S, Mazin I, Abu-Much A, Sabbag A, Katz M, Regev E, Chernomordik F, Guetta V, Segev A, Elian D, Barbash I, Fefer P, Narodistky M, Beigel R, Matetzky S. Effect of Chewing vs Swallowing Ticagrelor on Platelet Inhibition in Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 Dec 1;2(12):1380-1384. doi: 10.1001/jamacardio.2017.3868.

    PMID: 29071332DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeST Elevation Myocardial Infarction

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

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
MD

Study Record Dates

First Submitted

March 27, 2016

First Posted

March 31, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

IL(1)