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

• Sponsor: Jinling Hospital, China (Other)
• Overall Status: Completed
• CT.gov ID: NCT01163604
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CVD	Drug: Argatroban; Drug: non-argatroban treated group	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 4 Study of Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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; Other Names: Argartroban
Experimental: non-argatroban treated group Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.	Drug: non-argatroban treated group; Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.; Other Names: aspirin, clopidogrel

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Various Adverse Effects [at one year]

3. Clinical Endpoints [at one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu	China	210002

Sponsors and Collaborators

• Jinling Hospital, China

Investigators

• Study Chair: Xinfeng Liu, MD, Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinfeng Liu, Jinling Hospital, China, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT01163604
• Other Study ID Numbers: JLH
• First Posted: Jul 16, 2010
• Last Update Posted: Nov 23, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Xinfeng Liu, Jinling Hospital, China, Jinling Hospital, China: Argatroban; intracranial artery stenting; extracranial artery stenting; occlusion; restenosis
• Additional relevant MeSH terms: Aspirin; Argatroban; Clopidogrel

Study Results

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 Detail	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.

Arm/Group Title	Argatroban Group	"Aspirin" and "Clopidogrel" Interventions Group
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	58	56
COMPLETED	58	56
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Argatroban Group	Non-argatroban Treated Group	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	58	56	114
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.07 (11.87)	28.14 (11.46)	28.10 (11.64)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	58 100%	56 100%	114 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 12.1%	5 8.9%	12 10.5%
Male	51 87.9%	51 91.1%	102 89.5%
Region of Enrollment (participants) [Number]
China	58 100%	56 100%	114 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Occlusion and Restenosis at One Year
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Argatroban Group	Non-argatroban Treated Group
Arm/Group Description	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	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.
Measure Participants	58	56
Number [participants]	58 100%	56 100%

2. Secondary Outcome

Title	NIHSS, mRS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Various Adverse Effects
Time Frame	at one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Clinical Endpoints
Time Frame	at one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	1year
Adverse Event Reporting Description	Serious and Other [Non-Serious] Adverse Events were not collected
Arm/Group Title	Argatroban Group		Non-argatroban Treated Group
Arm/Group Description	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		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.
All Cause Mortality
	Argatroban Group		Non-argatroban Treated Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Argatroban Group		Non-argatroban Treated Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Argatroban Group		Non-argatroban Treated Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.