UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of intracoronary bolus abciximab application for patients who suffer from No-Reflow or Slow flow phenomenon during PCI
Title of the study (Brief title)	Effectiveness of intracoronary bolus abciximab application for No-Reflow or Slow flow phenomenon during PCI
Region	Japan

Condition
Condition	Patients suffer from No-Reflow or Slow flow phenomenon during PCI
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of intracoronary bolus abciximab application for patients who suffer from No-Reflow or Slow flow phenomenon during PCI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of attrition of ST elevation ratio :Comparison between at 30 minutes after PCI and at the time of maximum ST elevation
Key secondary outcomes	1. Rate of ST re-elevation after intracoronary bolus application of drug(s) 2. TIMI flow after PCI 3. Myocardial blush grade after PCI 4. Maximum value of CPK/CPK-MB after PCI 5. MACCE at 30 days / 1 year after PCI 6. Existence or nonexistence of serious hemorrhagic complication 7. Angiographical phenomenon at follow-up CAG

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Abciximab (+)
Interventions/Control_2	Abciximab (-)
Interventions/Control_3
Interventions/Control_4
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with coronary artery disease 2. Patients who take aspirin and thienopyridine 3. Informed consent was obtained from patients
Key exclusion criteria	1.with hemorrhagic diathesis and/or hypercoagulability 2.under emergent PCI 3.received thrombolytic therapy before PCI 4.more than twice the value of standard CPK and CPK-MB 5.be pregnant or nursing 6.with unprotected LMT disease
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuaki Mitsudo
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Address	Kurashiki city miwa 1-1-1, Okayama, Japan
TEL	086-422-0210
Email

Public contact
Name of contact person	Daiji Hasegawa
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Address	Kurashiki city miwa 1-1-1, Okayama, Japan
TEL	086-422-0210
Homepage URL
Email	dh10969@kchnet.or.jp

Sponsor
Institute	Department of Cardiology, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Department of Cardiology, Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	倉敷中央病院

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 07 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 19 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007101