Acute Coronary SyndromesPhase 4NCT02402400
Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity Study
A Phase 4 study testing Sub Lingual Ticagrelor in people with Acute Coronary Syndromes and Non ST Elevation Myocardial Infarction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) 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, Non ST Elevation Myocardial Infarction
- What is being tested?
- Sub Lingual Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Mar 2016
- 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 ACS/NSTEMI
- Informed, written consent
Who cannot join
- Age < 18 years or Age > 90 years
- Active bleeding; bleeding diathesis; coagulopathy
- Increased risk of bradycardiac events
- History of gastrointestinal or genitourinary bleeding <2 months
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
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- Suspected aortic dissection
- Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome
Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.
- Being tested
- Sub Lingual Ticagrelor
- Keywords
- NSTEMI
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub Lingual TicagrelorDrug
180mg sub-lingual ticagrelor
| Study group | Role | What they receive |
|---|---|---|
| Oral Ticagrelor | Active comparator | Not described Receives: Drug: Sub Lingual Ticagrelor |
| Sub Lingual Ticagrelor | Experimental | Not described Receives: Drug: Sub Lingual 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: 1hour
Secondary outcomes (3)
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD.
Measured: 1, 4-6, 12 hours
Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.
Measured: 24 hours
Occurrence of dyspnea and/or symptomatic bradycardia.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMar 2016
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
- NCT02402400
- Sponsor's protocol ID
- SHEBA-15-2028-15-SMC-EA-CTIL
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Asher E, Frydman S, Katz M, Regev E, Sabbag A, Mazin I, Abu-Much A, Kukuy A, Mazo A, Erez A, Berkovitch A, Narodistky M, Barbash I, Segev A, Beigel R, Matetzky S. Chewing versus Swallowing Ticagrelor to Accelerate Platelet Inhibition in Acute Coronary Syndrome - the CHEERS study. For The PLATIS (Platelets and Thrombosis in Sheba) Study Group. Thromb Haemost. 2017 Apr 3;117(4):727-733. doi: 10.1160/TH16-09-0728. Epub 2017 Feb 2.
PubMed 28150850
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02402400
- Acronym / sponsor ID
- SHEBA-15-2028-15-SMC-EA-CTIL
- Keywords
- NSTEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Mar 2015 (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.
Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in ACS/non ST-elevation Myocardial Infarction (NSTEMI) 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: Sub Lingual Ticagrelor |
| Sub Lingual Ticagrelor | Experimental | Drug: Sub Lingual 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 ACS/NSTEMI
- Informed, written consent
Key exclusion criteria (17 listed)
- Age < 18 years or Age > 90 years
- Active bleeding; bleeding diathesis; coagulopathy
- Increased risk of bradycardiac 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 |
|---|---|---|
| Sub Lingual Ticagrelor180mg sub-lingual ticagrelor | Drug | Oral Ticagrelor, Sub Lingual Ticagrelor |
Primary outcome
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
Time frame: 1hour
3 secondary outcomes
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6, 12 hours after ticagrelor LD.
Time frame: 1, 4-6, 12 hours
Bleeding events: Major, minor, minimal bleeding (TIMI criteria) events.
Time frame: 24 hours
Occurrence of dyspnea and/or symptomatic bradycardia.
Time frame: 24 hours
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 22 Mar 2016.
- Derived from this study: PubMed 28150850Asher E, Frydman S, Katz M, Regev E, Sabbag A, Mazin I, Abu-Much A, Kukuy A, Mazo A, Erez A, Berkovitch A, Narodistky M, Barbash I, Segev A, Beigel R, Matetzky S. Chewing versus Swallowing Ticagrelor to Accelerate Platelet Inhibition in Acute Coronary Syndrome - the CHEERS study. For The PLATIS (Platelets and Thrombosis in Sheba) Study Group. Thromb Haemost. 2017 Apr 3;117(4):727-733. doi: 10.1160/TH16-09-0728. Epub 2017 Feb 2.
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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 Sub Lingual Ticagrelor in people with Acute Coronary Syndromes and Non 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 17 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 22 Mar 2016. 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: 1hour). 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 NCT02402400, 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 22 Mar 2016.