- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410539
Mechanism Of Stent Thrombosis (MOST) Study (Most)
September 24, 2014 updated by: David Antoniucci, Careggi Hospital
Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry
This study is designed to assess the pathophysiology of ST by studying the main procedural and anatomical factors involved in the genesis of ST such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Florence, Italy
- Careggi Hospital, Department of Hearth and Vessels
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- previous PCI with bare metal stent (BMS) or drug eluting stent (DES) and a definite subacute coronary ST
- previous PCI with DES and a definite late or very late coronary ST
Exclusion Criteria:
- Development of ST within 72 hours of stent implantation (acute and early subacute ST).
- Late and very late ST of BMS.
- Absence of informed consent.
- Age less than 18 years.
- Creatinine values greater than 2.5 g/dl (this is to avoid the negative effects related to the contrast medium necessary to perform the OCT evaluation).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stent Thrombosis
Consecutive patients with stent thrombosis with stent strut assessment by OCT
|
OCT guided PCI.
Only thrombectomy in case of negative OCT findings (other than uncovered struts).
|
Active Comparator: Controls
Control subjects without stent thrombosis from the RHR OCT database
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OCT guided medical therapy.
Tailored antiplatelet therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of uncovered stent struts
Time Frame: After thrombectomy
|
The percentage of uncovered stent struts by OCT in patients with subacute stent thrombosis (either DES and BMS) and the percentage of uncovered stent struts in patients with late (after one month) and very late thrombosis of DES.
|
After thrombectomy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of malapposed stent struts
Time Frame: After Thrombectomy
|
The percentage of malapposed stent struts by OCT in patients with subacute thrombosis of DES and BMS and the percentage of malapposed stent struts by OCT in patients with late and very late thrombosis of DES.
|
After Thrombectomy
|
Percentage of patients with high residual platelet reactivity
Time Frame: Baseline
|
The percentage of patients with residual platelet reactivity (RPR) to ADP and arachidonic acid identified by values ≥ 240 P2Y12 reaction units (PRU) and ≥ 550 aspirin reaction units (ARU), respectively,.
during aspirin and clopidogrel therapy or in which one or both the antiplatelet drugs have been interrupted.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: David Antoniucci, MD, Careggi Hospital, Division of Invasive Cardiology
- Principal Investigator: Francesco Prati, MD, Rome Heart Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
August 4, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 5, 2011
Study Record Updates
Last Update Posted (Estimate)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 24, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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