Impact of Sarpogrelate in the Function of Endothelial Pro... | NCT01548274

Studies
Impact of Sarpogrelate in the Function of Endothelial Progenitor Cells

NCT01548274

Sponsor

Aichi Gakuin University

Status

Unknown status

Last Update Posted

Mar 8, 2012Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Atherosclerosis

Interventions

Sarpogrelate

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Mar 5, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2012

Last Update Posted Date

Mar 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effects of Sarpogrelate in endothelial progenitor cells of patients with atherosclerosis.

Detailed Description

Endothelial progenitor cells play an important role in vasculogenesis and vascular repair. Sarpogrelate, a inhibitor of HT2A, is used an an anti-platelet drug, however, a direct effect in vascular cells is supposed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Sarpogrelate	Drug	Sarpogrelate 300mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number and function of endothelial progenitor cells		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with atherosclerosis

Exclusion Criteria:

Patients with high risk of bleeding
Patients with pregnancy
Patients with allergic reaction of Salpogrelate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aichi-Gakuin University	Recruiting	Nagoya	Aichi-ken	464-8651	Japan

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C064294	sarpogrelate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided