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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014180
Receipt No. R000016514
Scientific Title Appropriate Dose of Initial Heparin Administration without Glycoprotein Inhibitor on Catheter Intervention
Date of disclosure of the study information 2014/06/06
Last modified on 2014/06/05

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Basic information
Public title Appropriate Dose of Initial Heparin Administration without Glycoprotein Inhibitor on Catheter Intervention
Acronym Appropriate Dose of Initial Heparin Administration on Catheter Intervention
Scientific Title Appropriate Dose of Initial Heparin Administration without Glycoprotein Inhibitor on Catheter Intervention
Scientific Title:Acronym Appropriate Dose of Initial Heparin Administration on Catheter Intervention
Region
Japan

Condition
Condition Coronary/peripheral artery disease planned with catheter intervention
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical trials in 1990's reported that activated clotting time (ACT) of 200 to 250 seconds under administration of glycoprotein IIb/IIIa inhibitor (GPI) appeared to be reasonable in terms of safety and efficacy during coronary angioplasty. However, there was few report about ACT kinetics in their procedures without GPI, and also appropriate amount of initial bolus injection of heparin was under discussion. Based on those backgrounds, we ought to evaluate relationship between initial dose of unfractionated heparin and bleeding/embolic complications.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes i) Time achieved with ACT>250 seconds
ii) Bleeding and embolic complications up to 30 days after the procedure
Key secondary outcomes i) Frequency of heparin addition during procedure
ii) Change of WBC/RBC/Platelets between before and after the procedure
iii) All-cause death, MACE

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients for staged catheter intervention on coronary and peripheral vessels were administered with 30 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.
Interventions/Control_2 Patients for staged catheter intervention on coronary and peripheral vessels were administered with 50 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.
Interventions/Control_3 Patients for staged catheter intervention on coronary and peripheral vessels were administered with 100 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.
Interventions/Control_4 Patients for staged catheter intervention on coronary and peripheral vessels were administered with 150 IU/kg of initial bolus unfractionated heparin. ACT is tested before and every 30 minutes after initial bolus, and 2,000 IU of additional heparin is administered if ACT is less than 250 seconds.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients for coronary or peripheral vessel intervention with informed consent, and without predicted demerit on heparin use.
Key exclusion criteria i) Emergent/urgent intervention
ii) Patients with malignant neoplasm whose life expectancies of less than 6 months
iii) Patients with active bleeding or embolic complications
iv) Patients with HIT(Heparin-Induced Thrombocytopenia)
v) Unsuitable patients for this trial judged by doctor-in-charge
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Email juken1123@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Homepage URL
Email juken1123@hotmail.co.jp

Sponsor
Institute Nishiarai Heart Center Hospital
Institute
Department

Funding Source
Organization Nishiarai Heart Center Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 05 Day
Last modified on
2014 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016514

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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