CVD
Conditions
Keywords
Argatroban, intracranial artery stenting, extracranial artery stenting, occlusion, restenosis
Brief summary
Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.
Detailed description
The risk of restenosis post intracranial and extracranial artery stenting is 20-40%, therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.
Interventions
DRUGArgatroban
Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment
Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* For extracranial artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%; according to intracranial artery lesion, stenting was considered for symptomatic stenosis≥70% in invalid patients after intensive medical therapy. * Successfully had intracranial or extracranial artery stenting
Exclusion criteria
* Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months * Hypersensitivity to contrast agent * Malignant hypertension * Difficult to perform the intracranial and extracranial artery stenting * Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc. * Serum creatinine \>1.5 mg/dL * Hypersensitivity to test drugs * Difficult to hand follow-up visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Occlusion and Restenosis at One Year | at one year | Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS, mRS | at one year | NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy. |
| Various Adverse Effects | at one year | — |
| Clinical Endpoints | at one year | — |
Countries
China
Participant flow
Recruitment details
The present study was a single-center, open-label, prospective, randomized, controlled pilot one. Enrollment of participants began in August 2010, and completed in August 2011. The local ethics committee approved the study, and written informed consent was obtained in all recruited patients.
Pre-assignment details
The present study was a single-center, open-label, prospective, randomized, controlled pilot one. Enrollment of participants began in August 2010, and completed in August 2011. The local ethics committee approved the study, and written informed consent was obtained in all recruited patients.
Participants by arm
| Arm | Count |
|---|---|
| Argatroban Group Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.
Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment | 58 |
| Non-argatroban Treated Group Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment. | 56 |
| Total | 114 |
Baseline characteristics
| Characteristic | Argatroban Group | Non-argatroban Treated Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 56 Participants | 114 Participants |
| Age, Continuous | 28.07 years STANDARD_DEVIATION 11.87 | 28.14 years STANDARD_DEVIATION 11.46 | 28.10 years STANDARD_DEVIATION 11.64 |
| Region of Enrollment China | 58 participants | 56 participants | 114 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Occlusion and Restenosis at One Year
Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%
Time frame: at one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argatroban Group | Number of Participants With Occlusion and Restenosis at One Year | 58 participants |
| Non-argatroban Treated Group | Number of Participants With Occlusion and Restenosis at One Year | 56 participants |
Secondary
Clinical Endpoints
Time frame: at one year
Secondary
NIHSS, mRS
NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.
Time frame: at one year
Secondary
Various Adverse Effects
Time frame: at one year