Acute Coronary SyndromesPhase 4NCT02725099
Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
A Phase 4 study testing Chewing Ticagrelor and Oral Ticagrelor in people with Acute Coronary Syndromes and ST Elevation Myocardial Infarction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndromes, ST Elevation Myocardial Infarction
- What is being tested?
- Chewing Ticagrelor and Oral 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 siteIsrael
- Study dates
- May 2016to Jan 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with STEMI
- Informed, written consent
Who cannot join
- Age < 18 years or Age > 90 years
- Active bleeding; bleeding diathesis; coagulopathy
- Increased risk of bradycardic events
- History of gastrointestinal or genitourinary bleeding <2 months
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
Show all 19Show fewer
- Suspected aortic dissection
- Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy <1 year)
- Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
- Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
- Known relevant hematological deviations: Hb <10 g/dl, PLT<100x10^9/l
- Use of coumadin derivatives within the last 7 days
- Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
- Known severe liver disease, severe renal failure
- Known allergy to the study medications
- Pregnancy
- Human immunodeficiency virus treatment
- The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days).
- If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
- Being tested
- Chewing Ticagrelor, Oral Ticagrelor
- Keywords
- STEMI
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing TicagrelorDrug
180 mg Chewing Ticagrelor
Oral TicagrelorDrug
180 mg oral Ticagrelor
| Study group | Role | What they receive |
|---|---|---|
| Oral Ticagrelor | Active comparator | Not described Receives: Drug: Oral Ticagrelor |
| Chewing Ticagrelor | Experimental | Not described Receives: Drug: Chewing Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Measured: 1 hour
Secondary outcomes (3)
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD
Measured: 1, 4-6 hours
Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
Measured: 30 days
Occurrence of dyspnea and/or symptomatic bradycardia
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Elad Asher, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725099
- Sponsor's protocol ID
- SHEBA-15-2824-EA-CTIL
- Status last verified
- Jan 2017
- First submitted
- 27 Mar 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Asher E, Tal S, Mazin I, Abu-Much A, Sabbag A, Katz M, Regev E, Chernomordik F, Guetta V, Segev A, Elian D, Barbash I, Fefer P, Narodistky M, Beigel R, Matetzky S. Effect of Chewing vs Swallowing Ticagrelor on Platelet Inhibition in Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 Dec 1;2(12):1380-1384. doi: 10.1001/jamacardio.2017.3868.
PubMed 29071332
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study
- ClinicalTrials.gov ID
- NCT02725099
- Acronym / sponsor ID
- SHEBA-15-2824-EA-CTIL
- Keywords
- STEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Ticagrelor | Active comparator | Drug: Oral Ticagrelor |
| Chewing Ticagrelor | Experimental | Drug: Chewing Ticagrelor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with STEMI
- Informed, written consent
Key exclusion criteria (19 listed)
- Age < 18 years or Age > 90 years
- Active bleeding; bleeding diathesis; coagulopathy
- Increased risk of bradycardic events
- History of gastrointestinal or genitourinary bleeding <2 months
- Major surgery in the last 6 weeks
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 |
|---|---|---|
| Chewing Ticagrelor180 mg Chewing Ticagrelor | Drug | Chewing Ticagrelor |
| Oral Ticagrelor180 mg oral Ticagrelor | Drug | Oral Ticagrelor |
Primary outcome
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Time frame: 1 hour
3 secondary outcomes
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD
Time frame: 1, 4-6 hours
Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events
Time frame: 30 days
Occurrence of dyspnea and/or symptomatic bradycardia
Time frame: 30 days
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 10 Jan 2017.
- Derived from this study: PubMed 29071332Asher E, Tal S, Mazin I, Abu-Much A, Sabbag A, Katz M, Regev E, Chernomordik F, Guetta V, Segev A, Elian D, Barbash I, Fefer P, Narodistky M, Beigel R, Matetzky S. Effect of Chewing vs Swallowing Ticagrelor on Platelet Inhibition in Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 Dec 1;2(12):1380-1384. doi: 10.1001/jamacardio.2017.3868.
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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 Chewing Ticagrelor and Oral Ticagrelor in people with Acute Coronary Syndromes and ST Elevation Myocardial Infarction, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 19 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 10 Jan 2017. 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 Israel. 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?
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725099, which also lists 1 linked publication.
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 10 Jan 2017.