NCT02261922

Brief Summary

To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated dilation of the brachial artery. This will be compared to prasugrel.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

October 7, 2014

Last Update Submit

October 9, 2014

Conditions

Antiplatelet Agents; Endothelial Function; Pleotropic Effects

Outcome Measures

Primary Outcomes (1)

  • flow mediated dilation of the brachial artery

    8 +/- 2 days

Study Arms (2)

ticagrelor

EXPERIMENTAL

ticagrelor treatment

Drug: ticagrelor

prasugrel

ACTIVE COMPARATOR

prasugrel treatment

Drug: prasugrel

Interventions

ticagrelorDRUG
ticagrelor
prasugrelDRUG
prasugrel

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Prior MI \> 1 year old
  • Prior PCI \> 1 year old
  • Prior CABG \> 3 months old
  • Known lesion causing more than 50% stenosis on coronary angiography

You may not qualify if:

  • Acute coronary syndrome within the last 6 months
  • Any history of bleeding
  • Age \> 75 years
  • Weight \< 65 kg
  • Prior stroke or TIA
  • Platelet count \< 100,000
  • Hemoglobin \< 11 mg/dL
  • Patients who have received ticagrelor, prasugrel or clopidogrel in the 3 months that preceded randomization
  • Patients who are taking anti-thrombotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de France Hospital

El Achrafiyé, Beyrouth, Beirut, Lebanon

RECRUITING

MeSH Terms

Interventions

TicagrelorPrasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Rabih Azar, MD, MPH

CONTACT

razar@usj.edu.lb

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiology, Hotel Dieu de France Hospital

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 10, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations

LE(1)