Ventricular Thrombosis Mural Following Myocardial InfarctionNCT01556659
LV Thrombus After Acute AMI: A Randomized Controlled Trial
A study testing Absence of vitamin K antagonist in people with Ventricular Thrombosis Mural Following Myocardial Infarction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST segment elevation myocardial infarction (STEMI). It is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K antagonist treatment in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Thrombosis Mural Following Myocardial Infarction
- What is being tested?
- Absence of vitamin K antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Jun 2022
- Phase
- Interventional
- 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
- Suspected Left Ventricular thrombus on echocardiography or routine Magnetic Resonance Imaging
- Ongoing treatment with dual antiplatelet therapy according to ESC/ACC-AHA guidelines at the time of randomization.
Who cannot join
- Younger than 18
- Clinically or hemodynamically unstable
- Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months
- Previous stroke or transient ischemic attack
- Scheduled for major surgery (including Coronary Artery Bypass Grafting) during the course of the study
- Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists
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- Contra-indication for vitamin K antagonist treatment
- Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study
- Congenital cardiac disease
- Presence of supraventricular or ventricular arrhythmias
- Expected candidate for ICD implantation with the next 6 months
- Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation 5 30mL/min)
- Known or symptomatic brain disease (such as brain tumor)
- Women who are pregnant.
- Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging (such as pacemaker, cerebrovascular clips, known contrast allergy, claustrophobia)
- Follow-up impossible (for example no fixed abode)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST segment elevation myocardial infarction (STEMI). It is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K antagonist treatment in these patients. However patients with STEMI nowadays undergo primary percutaneous coronary intervention (PCI) with coronary stent placement and consequently require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are currently treated with triple antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral. The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to address this issue.
Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of the study is to determine in a randomized fashion the risks and benefits of the addition of vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline Magnetic Resonance Imaging (MRI).
Read the detailed description
Design: A multicenter, prospective, randomized, non-inferiority trial with blinded evaluation of endpoints
Objective: The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation
Patients: Patients with acute myocardial infarction treated with primary PCI and LV thrombus on baseline echocardiography or baseline Magnetic Resonance Imaging. (MRI)
Methods: After written informed consent has been obtained, echocardiography and MRI are performed between 7-12 days after PCI. When LV thrombus is present on baseline MRI, patients are randomized to
- Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent,) and vitamin K antagonist (goal INR is 2.0 to 3.0))
- Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d).
Primary Endpoint: Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
Secondary Endpoints: The secondary endpoints as assessed at 6 and 12 months are:
- the composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism
- presence of new cerebral mirco-bleeds
- the occurrence of major and minor bleeding
- neurological status and quality of life.
- Being tested
- Absence of vitamin K antagonist
- Keywords
- Left ventricular thrombus, Acute myocardial infarction, Anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absence of vitamin K antagonistDrug
Also called warfarin
Dual anti-platelet therapy
| Study group | Role | What they receive |
|---|---|---|
| vitamin K antagonist + | No intervention | Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day) and vitamin K antagonist (acenocoumarol) |
| vitamin K antagonist - | Active comparator | Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day) Receives: Drug: Absence of vitamin K antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by Magnetic Resonance Imaging.
Measured: 6 months relative to baseline
Secondary outcomes (5)
The presence of new cerebral micro-bleeds assessed by MRI
Measured: At 6 months and 12 months relative to baseline
Occurrence of major and minor bleeding
Measured: At 6 and 12 months relative to baseline
Neurological status
Measured: At 6 and 12 months relative to baseline
Quality of life using a validated checklist
Measured: At 6 and 12 months relative to baseline
Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism
Measured: At 6 and 12 months relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2018
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Thrombosis Mural Following Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Erasmus Medical Center
- Responsible party
- Principal investigator, Jan Piek, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jan J Piek, Prof, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556659
- Sponsor's protocol ID
- 2011-004265-32
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2012
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens
- ClinicalTrials.gov ID
- NCT01556659
- Acronym / sponsor ID
- 2011-004265-32
- Keywords
- Left ventricular thrombus, Acute myocardial infarction, Anticoagulation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- VU University of Amsterdam, Erasmus Medical Center
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 16 Mar 2012 (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.
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST segment elevation myocardial infarction (STEMI). It is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K antagonist treatment in these patients. However patients with STEMI nowadays undergo primary percutaneous coronary intervention (PCI) with coronary stent placement and consequently require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are currently treated with triple antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral. The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to address this issue.
Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of the study is to determine in a randomized fashion the risks and benefits of the addition of vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline Magnetic Resonance Imaging (MRI).
Detailed description
Design: A multicenter, prospective, randomized, non-inferiority trial with blinded evaluation of endpoints
Objective: The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation
Patients: Patients with acute myocardial infarction treated with primary PCI and LV thrombus on baseline echocardiography or baseline Magnetic Resonance Imaging. (MRI)
Methods: After written informed consent has been obtained, echocardiography and MRI are performed between 7-12 days after PCI. When LV thrombus is present on baseline MRI, patients are randomized to
- Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent,) and vitamin K antagonist (goal INR is 2.0 to 3.0))
- Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d).
Primary Endpoint: Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
Secondary Endpoints: The secondary endpoints as assessed at 6 and 12 months are:
- the composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism
- presence of new cerebral mirco-bleeds
- the occurrence of major and minor bleeding
- neurological status and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin K antagonist + | No intervention | –Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day) and vitamin K antagonist (acenocoumarol) |
| vitamin K antagonist - | Active comparator | Drug: Absence of vitamin K antagonistTreatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected Left Ventricular thrombus on echocardiography or routine Magnetic Resonance Imaging
- Ongoing treatment with dual antiplatelet therapy according to ESC/ACC-AHA guidelines at the time of randomization.
Key exclusion criteria (16 listed)
- Younger than 18
- Clinically or hemodynamically unstable
- Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months
- Previous stroke or transient ischemic attack
- Scheduled for major surgery (including Coronary Artery Bypass Grafting) during the course of the study
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 |
|---|---|---|
| Absence of vitamin K antagonistAlso: warfarinDual anti-platelet therapy | Drug | vitamin K antagonist - |
Primary outcome
The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
Time frame: 6 months relative to baseline
Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by Magnetic Resonance Imaging.
5 secondary outcomes
The presence of new cerebral micro-bleeds assessed by MRI
Time frame: At 6 months and 12 months relative to baseline
Occurrence of major and minor bleeding
Time frame: At 6 and 12 months relative to baseline
Neurological status
Time frame: At 6 and 12 months relative to baseline
Quality of life using a validated checklist
Time frame: At 6 and 12 months relative to baseline
Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism
Time frame: At 6 and 12 months relative to baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Undecided
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.
Jan J Piek, Prof principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absence of vitamin K antagonist in people with Ventricular Thrombosis Mural Following Myocardial Infarction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 16 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: stopped early, as of the sponsor's last update on 25 Apr 2024. 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 Netherlands. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI. (time frame: 6 months relative to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.