Argatroban, Rt-PAPhase 4NCT03506009
Argatroban Plus r-tPA for Posterior Circulation Infarction（AR-PCI）
A Phase 4 study testing Argatroban combined with rt-PA and rt-PA in people with Argatroban, Rt-PA, run by Hui-Sheng Chen at 1 site in China.
Trial summary
Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Argatroban, Rt-PA
- What is being tested?
- Argatroban combined with rt-PA and rt-PA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2018to 13 Nov 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old;
- Diagnosis of posterior circulation ischemic stroke;
- Time from onset to treatment ≤6 hours;
- NIHSS: 4-25;
- Signed informed consent by patient self or legally authorized representatives.
Who cannot join
- mRS≥2;
- History of stroke within 3 months;
- History of intracranial hemorrhage;
- Suspected subarachnoid hemorrhage;
- Intracranial tumour, vascular malformation or arterial aneurysm;
- Major surgery within 1 month;
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- Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
- Platelet count < 105/mm3;
- Heparin therapy or oral anticoagulation therapy within 48 hours;
- Abnormal APTT;
- Thrombin or Xa factor inhibitor;
- Severe disease with a life expectancy of less than 3 months;
- Blood glucose < 50 mg/dL (2.7mmol/L);
- Patients who have received any other investigational drug or device within 3 months;
- Pregnancy;
- Researchers consider patients inappropriate to participate in the registry.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 10016
About this study
Official title: Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study
Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunction prognosis of thrombolytic patients has been a hot topic in the world.
Recent studies have found that the combined application of argatroban and rt-PA in the treatment of acute anterior circulation infarction might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.
Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of acute posterior circulation infarction.
- Conditions
- Argatroban, Rt-PA
- Being tested
- Argatroban combined with rt-PA, rt-PA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argatroban combined with rt-PADrug
Argatroban as a 100-ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%).
rt-PADrug
Intravenous throbolysis with 0.9mg/kg rtPA.
| Study group | Role | What they receive |
|---|---|---|
| Argatroban combined with rt-PA | Experimental | Not described Receives: Drug: Argatroban combined with rt-PA |
| rt-PA | Active comparator | Not described Receives: Drug: rt-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mRS (0-1）
Measured: 90±7 days
Secondary outcomes (4)
Early neurological deterioration
4 or more increase in NIHSS
Measured: 48 hours
Proportion of mRS (0-2）
Measured: 90±7 days
the occurence of stroke
Measured: 90±7 days
symptomatic intracranial hemorrhage
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start11 Jul 2018
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Why it stopped: it is very difficult to recruit qualified patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Argatroban, Rt-PAStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui-Sheng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506009
- Sponsor's protocol ID
- k(2017)29
- Status last verified
- Nov 2018
- First submitted
- 15 Apr 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study
- ClinicalTrials.gov ID
- NCT03506009
- Acronym / sponsor ID
- k(2017)29
- Conditions
- Argatroban, Rt-PA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: it is very difficult to recruit qualified patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hui-Sheng ChenUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 23 Apr 2018 (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.
Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunction prognosis of thrombolytic patients has been a hot topic in the world.
Recent studies have found that the combined application of argatroban and rt-PA in the treatment of acute anterior circulation infarction might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.
Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of acute posterior circulation infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argatroban combined with rt-PA | Experimental | Drug: Argatroban combined with rt-PA |
| rt-PA | Active comparator | Drug: rt-PA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years old;
- Diagnosis of posterior circulation ischemic stroke;
- Time from onset to treatment ≤6 hours;
- NIHSS: 4-25;
- Signed informed consent by patient self or legally authorized representatives.
Key exclusion criteria (16 listed)
- mRS≥2;
- History of stroke within 3 months;
- History of intracranial hemorrhage;
- Suspected subarachnoid hemorrhage;
- Intracranial tumour, vascular malformation or arterial aneurysm;
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 |
|---|---|---|
| Argatroban combined with rt-PAArgatroban as a 100-ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%). | Drug | Argatroban combined with rt-PA |
| rt-PAIntravenous throbolysis with 0.9mg/kg rtPA. | Drug | rt-PA |
Primary outcome
Proportion of mRS (0-1）
Time frame: 90±7 days
4 secondary outcomes
Early neurological deterioration
Time frame: 48 hours
Proportion of mRS (0-2）
Time frame: 90±7 days
the occurence of stroke
Time frame: 90±7 days
symptomatic intracranial hemorrhage
Time frame: 36 hours
Results and safety
The study was stopped early (reason given: it is very difficult to recruit qualified patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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 Argatroban combined with rt-PA and rt-PA in people with Argatroban, Rt-PA, run by Hui-Sheng Chen at 1 site 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 16 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 14 Nov 2018. 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 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. 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 was stopped early (reason given: it is very difficult to recruit qualified patients). 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?
Proportion of mRS (0-1） (time frame: 90±7 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 14 Nov 2018.