Ischemic StrokePhase 2/3MR TEANCT03357133
Tirofiban for Patients Treated With Alteplase
A Phase 2/3 study testing Tirofiban and Alteplase in people with Ischemic Stroke, run by Capital Medical University at 7 sites in China.
Trial summary
After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tirofiban and Alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 7 sitesChina
- Study dates
- 16 Dec 2017to 31 Aug 2020
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.
- 6≤ NIHSS ≤20 before IV tPA, or NIHSS >20 but decrease ≥ 8 after IV rt-PA.
- ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage
- Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form
Who cannot join
- Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.
- Patients had used antiplatelet therapy in the past 5 days before the stroke.
- Patients had used anticoagulant therapy in the past 5 days before the stroke.
- Scheduled for surgery or interventional treatment requiring study drug cessation.
- CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.
- Any evidence of clinically significant bleeding ,or known coagulopathy.
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- Renal insufficiency (creatinine clearance rate <30ml/min)
- Hepatic dysfunction (ALT >2 folds of Upper limit of normal value or AST>2 folds of Upper limit of normal value).
- Pre-existing disability with ≥ mRS 2.
- Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.
- Severe non-cerebrovascular disease with life expectancy <3 months
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
The Central Hospital of Luohe City
Luohe, Henan
Luzhou People's Hospital
Luzhou, Sichuan
Suzhou Municipal Hoapital
Suzhou, Anhui
Xiangtan Central Hospital
Xiangtan
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis
After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.
- Conditions
- Ischemic Stroke
- Being tested
- Tirofiban, Alteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Tirofiban Injection after the alteplase intravenous thrombolysis
AlteplaseDrug
Only alteplase intravenous thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban and alteplase | Experimental | Not described Receives: Drug: Tirofiban |
| Alteplase | Placebo comparator | Not described Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of favorable outcome
favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale
Measured: 90 days
Secondary outcomes (4)
mRS ≤2
Measured: 90 days
NIHSS score
Measured: 7 days
Deterioration after improvement
Measured: 24 hours
Final infarct size
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 posted29 Nov 2017
- Study start16 Dec 2017
- Primary completion1 Jun 2020
- Study completion31 Aug 2020
Why it stopped: The number and speed of enrollment were significantly less than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357133
- Sponsor's protocol ID
- 2017032
- Acronym
- MR TEA
- Status last verified
- Sep 2020
- First submitted
- 23 Nov 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis
- ClinicalTrials.gov ID
- NCT03357133
- Acronym / sponsor ID
- MR TEA / 2017032
- Conditions
- Ischemic Stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number and speed of enrollment were significantly less than expected.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Dec 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 29 Nov 2017 (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.
After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban and alteplase | Experimental | Drug: Tirofiban |
| Alteplase | Placebo comparator | Drug: Alteplase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18
- Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.
- 6≤ NIHSS ≤20 before IV tPA, or NIHSS >20 but decrease ≥ 8 after IV rt-PA.
- ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage
- Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form
Key exclusion criteria (11 listed)
- Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.
- Patients had used antiplatelet therapy in the past 5 days before the stroke.
- Patients had used anticoagulant therapy in the past 5 days before the stroke.
- Scheduled for surgery or interventional treatment requiring study drug cessation.
- CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.
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 |
|---|---|---|
| TirofibanTirofiban Injection after the alteplase intravenous thrombolysis | Drug | Tirofiban and alteplase |
| AlteplaseOnly alteplase intravenous thrombolysis | Drug | Alteplase |
Primary outcome
The rate of favorable outcome
Time frame: 90 days
favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale
4 secondary outcomes
mRS ≤2
Time frame: 90 days
NIHSS score
Time frame: 7 days
Deterioration after improvement
Time frame: 24 hours
Final infarct size
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: The number and speed of enrollment were significantly less than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tirofiban and Alteplase in people with Ischemic Stroke, run by Capital Medical University at 7 sites in China.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: The number and speed of enrollment were significantly less than expected.). Results are not available in the source record.
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?
The rate of favorable outcome (time frame: 90 days). 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 9 Sep 2020.