Back to resultsPlatelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Prasugrel
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- between 18 and 75 years old
- were on aspirin
- without P2Y12 inhibitor at baseline
- > 1 year after documented acute coronary syndrome
Exclusion Criteria:
- use of oral anticoagulation or P2Y12 at baseline
- Weight < 60kg
- History of tia or stroke
- Any coagulation disorders
- Refuse to sign the written consent
Sites / Locations
- Heart Institute (InCor) / University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prasugrel group
Ticagrelor group
Arm Description
Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days) + Ticagrelor placebo (Placebo loading dose followed by two pills a day)
Ticagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05247385
First Posted
January 4, 2022
Last Updated
February 9, 2022
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05247385
Brief Title
Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel
Official Title
Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
This was a prospective, double blinded, randomized trial that compared platelet inhibition and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg BID) versus prasugrel (60mg loading dose, followed by 10 mg QD) .
Patients were eligible if they were between 18 and 75 years old, were on aspirin without P2Y12 inhibitor at baseline and > 1 year after documented ACS. Platelet aggregation was compared with the Multiplate ADP® assay, performed at baseline and after 15 days on study medication. Adenosine plasma levels were measured with high performance liquid chromatography at the same time points
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel group
Arm Type
Active Comparator
Arm Description
Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days)
+ Ticagrelor placebo (Placebo loading dose followed by two pills a day)
Arm Title
Ticagrelor group
Arm Type
Active Comparator
Arm Description
Ticagrelor (180mg loading dose, followed by 90 mg BID)
+ Prasugrel placebo (Placebo loading dose followed by one pill a day)
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Compared platelet inhibition and adenosine levels at baseline and after 15 days
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Compared platelet inhibition and adenosine levels at baseline and after 15 days
Primary Outcome Measure Information:
Title
To compare platelet inhibition between the two groups (ticagrelor and prasugrel)
Description
Platelet aggregation was compared with the Multiplate ADP® assay at baseline and after 15 days on study medication
Time Frame
15 days
Title
To compare adenosine levels between the two groups (ticagrelor and prasugrel)
Description
Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between 18 and 75 years old
were on aspirin
without P2Y12 inhibitor at baseline
> 1 year after documented acute coronary syndrome
Exclusion Criteria:
use of oral anticoagulation or P2Y12 at baseline
Weight < 60kg
History of tia or stroke
Any coagulation disorders
Refuse to sign the written consent
Facility Information:
Facility Name
Heart Institute (InCor) / University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel
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