Phase 4
Completed N=114
Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
CVD
Source: ClinicalTrials.gov NCT01163604 ↗
Enrolled (actual)
114
Serious AEs
—
Results posted
Nov 2014
Primary outcomePrimary: Number of Participants With Occlusion and Restenosis at One Year — 58; 56 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Occlusion and Restenosis at One Year |
58; 56 | — |
| SECONDARY NIHSS, mRS |
— | — |
| SECONDARY Various Adverse Effects |
— | — |
| SECONDARY Clinical Endpoints |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01163604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.