Trial Outcomes & Findings for Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting (NCT NCT01163604)

Results Overview

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%

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

114 participants

Primary outcome timeframe

at one year

Results posted on

2015-11-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	"Aspirin" and "Clopidogrel" Interventions 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.
Overall Study STARTED	58	56
Overall Study COMPLETED	58	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Argatroban Group n=58 Participants 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	Non-argatroban Treated Group n=56 Participants 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.	Total n=114 Participants Total of all reporting groups
Age, Continuous	28.07 years STANDARD_DEVIATION 11.87 • n=5 Participants	28.14 years STANDARD_DEVIATION 11.46 • n=7 Participants	28.10 years STANDARD_DEVIATION 11.64 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	56 Participants n=7 Participants	114 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Region of Enrollment China	58 participants n=5 Participants	56 participants n=7 Participants	114 participants n=5 Participants

PRIMARY outcome

Timeframe: 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%

Outcome measures

Outcome measures
Measure	Argatroban Group n=58 Participants 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	Non-argatroban Treated Group n=56 Participants 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.
Number of Participants With Occlusion and Restenosis at One Year	58 participants	56 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at one year

Outcome measures

Outcome data not reported

Adverse Events

Argatroban Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-argatroban Treated Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

xinfeng Liu

jinling hospital

Phone: 025-84801861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place