NCT05247385

Brief Summary

Prospective, single-center, double blind, double dummy, randomized trial. Platelet function tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary artery disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_4 coronary-artery-disease

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

Study Start

First participant enrolled

March 20, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

3.9 years

First QC Date

January 4, 2022

Last Update Submit

February 9, 2022

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • To compare platelet inhibition between the two groups (ticagrelor and prasugrel)

    Platelet aggregation was compared with the Multiplate ADP® assay at baseline and after 15 days on study medication

    15 days

  • To compare adenosine levels between the two groups (ticagrelor and prasugrel)

    Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points

    15 days

Study Arms (2)

Prasugrel group

ACTIVE COMPARATOR

Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days) \+ Ticagrelor placebo (Placebo loading dose followed by two pills a day)

Drug: PrasugrelDrug: Ticagrelor

Ticagrelor group

ACTIVE COMPARATOR

Ticagrelor (180mg loading dose, followed by 90 mg BID) \+ Prasugrel placebo (Placebo loading dose followed by one pill a day)

Drug: PrasugrelDrug: Ticagrelor

Interventions

PrasugrelDRUG

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Prasugrel groupTicagrelor group
TicagrelorDRUG

Compared platelet inhibition and adenosine levels at baseline and after 15 days

Prasugrel groupTicagrelor group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 and 75 years old
  • were on aspirin
  • without P2Y12 inhibitor at baseline
  • \> 1 year after documented acute coronary syndrome

You may not qualify if:

  • use of oral anticoagulation or P2Y12 at baseline
  • Weight \< 60kg
  • History of tia or stroke
  • Any coagulation disorders
  • Refuse to sign the written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Prasugrel HydrochlorideTicagrelor

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Coronary Care Unit

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 18, 2022

Study Start

March 20, 2017

Primary Completion

February 26, 2021

Study Completion

December 20, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)