Coronary Artery DiseasePhase 4NCT05247385
Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel
A Phase 4 study testing Prasugrel and Ticagrelor in people with Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prasugrel and Ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2017to 20 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 75 years old
- were on aspirin
- without P2Y12 inhibitor at baseline
- > 1 year after documented acute coronary syndrome
Who cannot join
- use of oral anticoagulation or P2Y12 at baseline
- Weight < 60kg
- History of tia or stroke
- Any coagulation disorders
- Refuse to sign the written consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) / University of São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel
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
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- Prasugrel, Ticagrelor
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Compared platelet inhibition and adenosine levels at baseline and after 15 days
TicagrelorDrug
Compared platelet inhibition and adenosine levels at baseline and after 15 days
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Prasugrel; Drug: 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) Receives: Drug: Prasugrel; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start20 Mar 2017
- Primary completion26 Feb 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos Nicolau, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247385
- Sponsor's protocol ID
- 4086/14/066
- Status last verified
- Feb 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel
- ClinicalTrials.gov ID
- NCT05247385
- Acronym / sponsor ID
- 4086/14/066
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel group | Active comparator | Drug: Prasugrel, Drug: TicagrelorPrasugrel (60mg loading dose, followed by 10 mg QD for 15 days) + Ticagrelor placebo (Placebo loading dose followed by two pills a day) |
| Ticagrelor group | Active comparator | Drug: Prasugrel, Drug: TicagrelorTicagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18 and 75 years old
- were on aspirin
- without P2Y12 inhibitor at baseline
- > 1 year after documented acute coronary syndrome
Key exclusion criteria (5 listed)
- use of oral anticoagulation or P2Y12 at baseline
- Weight < 60kg
- History of tia or stroke
- Any coagulation disorders
- Refuse to sign the written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrasugrelCompared platelet inhibition and adenosine levels at baseline and after 15 days | Drug | Prasugrel group, Ticagrelor group |
| TicagrelorCompared platelet inhibition and adenosine levels at baseline and after 15 days | Drug | Prasugrel group, Ticagrelor group |
Primary outcome
To compare platelet inhibition between the two groups (ticagrelor and prasugrel)
Time frame: 15 days
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)
Time frame: 15 days
Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel and Ticagrelor in people with Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare platelet inhibition between the two groups (ticagrelor and prasugrel) (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.