Coronary ArteryPhase 4MostNCT01410539
Mechanism Of Stent Thrombosis (MOST) Study
A Phase 4 study testing OCT guided PCI and OCT guided medical therapy in people with Coronary Artery and Stent Thrombosis, run by Careggi Hospital at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery, Stent Thrombosis, Platelet
- What is being tested?
- OCT guided PCI and OCT guided medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery, Stent Thrombosis, Platelet, Thrombus
- Being tested
- OCT guided PCI, OCT guided medical therapy
- Keywords
- Stent Thrombosis, Percutaneous Coronary Intervention, Bare Metal Stent, Drug Eluting Stent, Residual Platelet Reactivity, Optical Coherence Tomography, OCT
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guided PCIDevice
OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
OCT guided medical therapyDrug
OCT guided medical therapy. Tailored antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| Stent Thrombosis | Experimental | Consecutive patients with stent thrombosis with stent strut assessment by OCT Receives: Device: OCT guided PCI |
| Controls | Active comparator | Control subjects without stent thrombosis from the RHR OCT database Receives: Drug: OCT guided medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of uncovered stent struts
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.
Measured: After thrombectomy
Secondary outcomes (2)
Percentage of malapposed stent struts
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.
Measured: After Thrombectomy
Percentage of patients with high residual platelet reactivity
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Antoniucci, Careggi Hospital
- Investigators
- David Antoniucci, MD, Study chair, Careggi Hospital, Division of Invasive CardiologyFrancesco Prati, MD, Principal investigator, Rome Heart Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410539
- Sponsor's protocol ID
- MOST Study
- Acronym
- Most
- Status last verified
- Sep 2014
- First submitted
- 4 Aug 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parodi G, La Manna A, Di Vito L, Valgimigli M, Fineschi M, Bellandi B, Niccoli G, Giusti B, Valenti R, Cremonesi A, Biondi-Zoccai G, Prati F. Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the Mechanism Of Stent Thrombosis (MOST) study. EuroIntervention. 2013 Dec;9(8):936-44. doi: 10.4244/EIJV9I8A157.
PubMed 24384290
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry
- ClinicalTrials.gov ID
- NCT01410539
- Acronym / sponsor ID
- Most / MOST Study
- Conditions
- Coronary Artery, Stent Thrombosis, Platelet, Thrombus
- Keywords
- Stent Thrombosis, Percutaneous Coronary Intervention, Bare Metal Stent, Drug Eluting Stent, Residual Platelet Reactivity, Optical Coherence Tomography, OCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent Thrombosis | Experimental | Device: OCT guided PCIConsecutive patients with stent thrombosis with stent strut assessment by OCT |
| Controls | Active comparator | Drug: OCT guided medical therapyControl subjects without stent thrombosis from the RHR OCT database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT guided PCIOCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts). | Device | Stent Thrombosis |
| OCT guided medical therapyOCT guided medical therapy. Tailored antiplatelet therapy. | Drug | Controls |
Primary outcome
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.
2 secondary outcomes
Percentage of malapposed stent struts
Time frame: After Thrombectomy
Percentage of patients with high residual platelet reactivity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Derived from this study: PubMed 24384290Parodi G, La Manna A, Di Vito L, Valgimigli M, Fineschi M, Bellandi B, Niccoli G, Giusti B, Valenti R, Cremonesi A, Biondi-Zoccai G, Prati F. Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the Mechanism Of Stent Thrombosis (MOST) study. EuroIntervention. 2013 Dec;9(8):936-44. doi: 10.4244/EIJV9I8A157.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Antoniucci, MD study chair
Careggi Hospital, Division of Invasive Cardiology
Francesco Prati, MD principal investigator
Rome Heart Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OCT guided PCI and OCT guided medical therapy in people with Coronary Artery and Stent Thrombosis, run by Careggi Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of uncovered stent struts (time frame: After thrombectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.