Coronary Artery DiseasePhase 4DISSOLUTIONNCT01568931
Local Thrombolytics Before Thrombectomy in STEMI
A Phase 4 study testing Urokinase and Saline in people with Coronary Artery Disease, run by University of Roma La Sapienza.
Trial summary
Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Urokinase and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2021
- 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
- ST-elevation myocardial infarction
- angiographic evidence of massive thrombosis in the culprit artery
- Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
- Able to understand and willing to sign the informed CF
Who cannot join
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
About this study
Official title: Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial
Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.
Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.
Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.
Read the detailed description
The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).
Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution
- Conditions
- Coronary Artery Disease
- Being tested
- Urokinase, Saline
- Keywords
- thrombectomy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrokinaseDrug
Also called UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ
intracoronary, urokinase, 200,000 Units, bolus
SalineDrug
Also called Saline infusion
intracoronary, saline, bolus 1 cc
| Study group | Role | What they receive |
|---|---|---|
| Urokinase | Active comparator | Patients will be randomized to to receive local bolus of 200,000 units urokinase Receives: Drug: Urokinase |
| Saline | Active comparator | Patients will be randomized to to receive local bolus of intracoronary saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes at 30 days
30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
Measured: Up to 30 days
Secondary outcomes (3)
Myocardial reperfusion after Primary CI
ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
Measured: Up to 90 minutes after Primary PCI
Left ventricular remodeling
A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography
Measured: Up to 1 year after Primary PCI
5-year MACE
Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure
Measured: Up to 5 years after Primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJan 2014
- Primary completionMar 2020
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Cesare Greco, MD, Study director, University Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568931
- Sponsor's protocol ID
- 197/2012/D
- Acronym
- DISSOLUTION
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2012
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial
- ClinicalTrials.gov ID
- NCT01568931
- Acronym / sponsor ID
- DISSOLUTION / 197/2012/D
- Conditions
- Coronary Artery Disease
- Keywords
- thrombectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 2 Apr 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.
Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.
Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.
Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.
Detailed description
The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).
Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urokinase | Active comparator | Drug: UrokinasePatients will be randomized to to receive local bolus of 200,000 units urokinase |
| Saline | Active comparator | Drug: SalinePatients will be randomized to to receive local bolus of intracoronary saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ST-elevation myocardial infarction
- angiographic evidence of massive thrombosis in the culprit artery
- Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
- Able to understand and willing to sign the informed CF
Key exclusion criteria (1 listed)
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
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 |
|---|---|---|
| UrokinaseAlso: UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZintracoronary, urokinase, 200,000 Units, bolus | Drug | Urokinase |
| SalineAlso: Saline infusionintracoronary, saline, bolus 1 cc | Drug | Saline |
Primary outcome
Outcomes at 30 days
Time frame: Up to 30 days
30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
3 secondary outcomes
Myocardial reperfusion after Primary CI
Time frame: Up to 90 minutes after Primary PCI
Left ventricular remodeling
Time frame: Up to 1 year after Primary PCI
5-year MACE
Time frame: Up to 5 years after Primary PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Related trials for Coronary Artery Disease
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Cesare Greco, MD study director
University Sapienza
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Urokinase and Saline in people with Coronary Artery Disease, run by University of Roma La Sapienza.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Outcomes at 30 days (time frame: Up to 30 days). 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 8 Apr 2020; AzTrials last refreshed its copy on 1 Nov 2026.