NCT02402400

Brief Summary

Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) 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 Jul 2015

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 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

March 25, 2015

Last Update Submit

March 19, 2016

Conditions

Acute Coronary SyndromesNon ST Elevation Myocardial Infarction

Keywords

NSTEMI

Outcome Measures

Primary Outcomes (1)

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

    1hour

Secondary Outcomes (3)

  • The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD.

    1, 4-6, 12 hours

  • Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.

    24 hours

  • Occurrence of dyspnea and/or symptomatic bradycardia.

    24 hours

Study Arms (2)

Oral Ticagrelor

ACTIVE COMPARATOR
Drug: Sub Lingual Ticagrelor

Sub Lingual Ticagrelor

EXPERIMENTAL
Drug: Sub Lingual Ticagrelor

Interventions

Sub Lingual TicagrelorDRUG

180mg sub-lingual ticagrelor

Oral TicagrelorSub Lingual Ticagrelor

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with ACS/NSTEMI
  • Informed, written consent

You may not qualify if:

  • Age \< 18 years or Age \> 90 years
  • Active bleeding; bleeding diathesis; coagulopathy
  • Increased risk of bradycardiac 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, 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
  • +2 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, Frydman S, Katz M, Regev E, Sabbag A, Mazin I, Abu-Much A, Kukuy A, Mazo A, Erez A, Berkovitch A, Narodistky M, Barbash I, Segev A, Beigel R, Matetzky S. Chewing versus Swallowing Ticagrelor to Accelerate Platelet Inhibition in Acute Coronary Syndrome - the CHEERS study. For The PLATIS (Platelets and Thrombosis in Sheba) Study Group. Thromb Haemost. 2017 Apr 3;117(4):727-733. doi: 10.1160/TH16-09-0728. Epub 2017 Feb 2.

    PMID: 28150850DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

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

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, MHA

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 30, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

IL(1)