Acute Coronary SyndromePhase 4TICA-MASTICANCT04567290
Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
A Phase 4 study testing Chewed ticagrelor and Swallowed ticagrelor in people with Acute Coronary Syndrome, run by Centro Hospitalario La Concepcion at 1 site in Mexico.
Trial summary
The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Chewed ticagrelor and Swallowed ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 7 Oct 2020to 30 Sep 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention
Who cannot join
- Age <18 years
- Known coagulopathy, bleeding diathesis, or active bleeding
- History of recent gastrointestinal or genitourinary bleeding within 2 months
- Previous therapy with clopidogrel, prasugrel, or ticagrelor
- Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure
- Major surgery within 6 weeks
Show all 20Show fewer
- History of intracranial bleeding or intracraneal neoplasm
- Suspected aortic dissection
- Chronic obstructive pulmonary disease
- Severe hemodynamic instability or cardiogenic shock
- Resuscitated cardiac arrest
- Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days
- Life expectancy <1 year
- Known severe liver or renal disease, GFR estimated by CKD-EPI <30 ml/min/1.73 m2
- Known HIV treatment
- Hemoglobin <10 g/dL
- Platelet count <100,000/L
- Pregnancy
- Known allergy to ticagrelor
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital La Concepción
Saltillo, Coahuila
Carlos Felipe Barrera Ramírez, MD
About this study
The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention
- Conditions
- Acute Coronary Syndrome
- Being tested
- Chewed ticagrelor, Swallowed ticagrelor
- Keywords
- Ticagrelor, Platelet aggregation inhibitors, VerifyNow, Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewed ticagrelorDrug
Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
Swallowed ticagrelorDrug
Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
| Study group | Role | What they receive |
|---|---|---|
| Chewed ticagrelor | Experimental | Ticagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff.
Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed Receives: Drug: Chewed ticagrelor |
| Swallowed ticagrelor | Active comparator | Ticagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water.
Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed Receives: Drug: Swallowed ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Platelet reactivity measured with VerifyNow (PRU)
Measured: 1 hour
Secondary outcomes (4)
Efficacy (MACCE)
Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction
Measured: 30 days
Composite outcome
Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition
Measured: 30 days
Efficacy (long term)
Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined)
Measured: 1 year
High platelet reactivity on treatment rate
Inhibition of platelet aggregation (IPA) measured by VerifyNow
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start7 Oct 2020
- Primary completion15 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalario La Concepcion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567290
- Sponsor's protocol ID
- 12345
- Acronym
- TICA-MASTICA
- Status last verified
- Jul 2021
- First submitted
- 21 Sep 2020
- Last updated
- 29 Jul 2021
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04567290
- Acronym / sponsor ID
- TICA-MASTICA / 12345
- Conditions
- Acute Coronary Syndrome
- Keywords
- Ticagrelor, Platelet aggregation inhibitors, VerifyNow, Acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centro Hospitalario La ConcepcionUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 28 Sep 2020 (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.
The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewed ticagrelor | Experimental | Drug: Chewed ticagrelorTicagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff. Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed |
| Swallowed ticagrelor | Active comparator | Drug: Swallowed ticagrelorTicagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water. Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention
Key exclusion criteria (20 listed)
- Age <18 years
- Known coagulopathy, bleeding diathesis, or active bleeding
- History of recent gastrointestinal or genitourinary bleeding within 2 months
- Previous therapy with clopidogrel, prasugrel, or ticagrelor
- Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure
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 |
|---|---|---|
| Chewed ticagrelorChewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets | Drug | Chewed ticagrelor |
| Swallowed ticagrelorSwallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets | Drug | Swallowed ticagrelor |
Primary outcome
Platelet reactivity
Time frame: 1 hour
Platelet reactivity measured with VerifyNow (PRU)
4 secondary outcomes
Efficacy (MACCE)
Time frame: 30 days
Composite outcome
Time frame: 30 days
Efficacy (long term)
Time frame: 1 year
High platelet reactivity on treatment rate
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- 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.
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 Chewed ticagrelor and Swallowed ticagrelor in people with Acute Coronary Syndrome, run by Centro Hospitalario La Concepcion at 1 site in Mexico.
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 1 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 29 Jul 2021. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Felipe Barrera Ramírez, MD (8441602269, carlosfbarrera@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (time frame: 1 hour). 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 29 Jul 2021.