Acute Coronary SyndromeATTRACTIVENCT05554588
Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
A study testing Intrathrombus Thrombolysis During Primary PCI and Aspiration Thrombectomy During Primary PCI in people with Acute Coronary Syndrome and ST Elevation Myocardial Infarction, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- What is being tested?
- Intrathrombus Thrombolysis During Primary PCI and Aspiration Thrombectomy During Primary PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 1 Sep 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with:
- Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
- Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
- Referred for PPCI
- Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia
- High thrombus burden:
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- TIMI thrombus grade 3 or 4 after emergency coronary angiography
- Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5
- Informed consent
Who cannot join
- Rescue PCI after systemic thrombolysis
- Previous CABG history
- Life expectancy<1 year
- Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
- Serious hepatic or kidney dysfunction
- Pregnancy and lactation
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- Uncontrolled hypertension (>180/100mmHg)
- Previous hemorrhagic stroke or ischemic stroke in past 3 months
- Cardiogenic shock or cardio-pulmonary resuscitation
- Informed consent cannot be obtained or follow-up cannot be completed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhen Zhang, +8615210849352, bjmuzz@163.com
About this study
Official title: A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden
This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).
Read the detailed description
The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.
- Conditions
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- Being tested
- Intrathrombus Thrombolysis During Primary PCI, Aspiration Thrombectomy During Primary PCI
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathrombus Thrombolysis During Primary PCIProcedure or surgery
Intrathrombus Thrombolysis During Primary PCI
Aspiration Thrombectomy During Primary PCIProcedure or surgery
Aspiration Thrombectomy During Primary PCI
| Study group | Role | What they receive |
|---|---|---|
| Intrathrombus thrombolysis | Active comparator | Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI Receives: Procedure: Intrathrombus Thrombolysis During Primary PCI |
| Aspiration thrombectomy | Active comparator | Aspiration thrombectomy during PPCI Receives: Procedure: Aspiration Thrombectomy During Primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major adverse cardiovascular events (MACEs)
Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization
Measured: up to 180 days
Secondary outcomes (3)
Rate of ischemic stroke and transient ischemic attack (TIA)
Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days
Measured: up to 30 days
Rate of major bleeding evens (BARC type 2, 3 and 5)
Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days
Measured: up to 30 days
Rate of key net benefit outcome
cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis, target-vessel revascularization, stroke and major bleeding evens (BARC 2,3 and 5)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start13 Sep 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
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 Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingang Zheng, China-Japan Friendship Hospital
- Investigators
- Jingang Zheng, Doctor, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554588
- Sponsor's protocol ID
- CSCF2021B02
- Acronym
- ATTRACTIVE
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Z, Sheng Z, Che W, An S, Sun D, Zhai Z, Zhao X, Yang Y, Meng Z, Ye Z, Xie E, Li P, Yu C, Gao Y, Xiao Z, Wu Y, Dong F, Ren J, Zheng J. Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden. BMJ Open. 2023 Nov 10;13(11):e076476. doi: 10.1136/bmjopen-2023-076476.
PubMed 37949622
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden
- ClinicalTrials.gov ID
- NCT05554588
- Acronym / sponsor ID
- ATTRACTIVE / CSCF2021B02
- Conditions
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Sep 2022 (actual)
- 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 is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).
Detailed description
The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathrombus thrombolysis | Active comparator | Procedure: Intrathrombus Thrombolysis During Primary PCIIntrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI |
| Aspiration thrombectomy | Active comparator | Procedure: Aspiration Thrombectomy During Primary PCIAspiration thrombectomy during PPCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients presenting with:
- Referred for PPCI
- Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia
- High thrombus burden:
- Informed consent
Key exclusion criteria (10 listed)
- Rescue PCI after systemic thrombolysis
- Previous CABG history
- Life expectancy<1 year
- Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
- Serious hepatic or kidney dysfunction
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 |
|---|---|---|
| Intrathrombus Thrombolysis During Primary PCIIntrathrombus Thrombolysis During Primary PCI | Procedure or surgery | Intrathrombus thrombolysis |
| Aspiration Thrombectomy During Primary PCIAspiration Thrombectomy During Primary PCI | Procedure or surgery | Aspiration thrombectomy |
Primary outcome
Rate of major adverse cardiovascular events (MACEs)
Time frame: up to 180 days
Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization
3 secondary outcomes
Rate of ischemic stroke and transient ischemic attack (TIA)
Time frame: up to 30 days
Rate of major bleeding evens (BARC type 2, 3 and 5)
Time frame: up to 30 days
Rate of key net benefit outcome
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Derived from this study: PubMed 37949622Zhang Z, Sheng Z, Che W, An S, Sun D, Zhai Z, Zhao X, Yang Y, Meng Z, Ye Z, Xie E, Li P, Yu C, Gao Y, Xiao Z, Wu Y, Dong F, Ren J, Zheng J. Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden. BMJ Open. 2023 Nov 10;13(11):e076476. doi: 10.1136/bmjopen-2023-076476.
- Individual participant dataSharing planned: No
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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.
Jingang Zheng, Doctor study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathrombus Thrombolysis During Primary PCI and Aspiration Thrombectomy During Primary PCI in people with Acute Coronary Syndrome and ST Elevation Myocardial Infarction, run by China-Japan Friendship Hospital at 1 site in China.
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 9 inclusion and 10 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 26 Sep 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Zhang, Doctor (+86 15210849352, bjmuzz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major adverse cardiovascular events (MACEs) (time frame: up to 180 days). 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 NCT05554588, 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 26 Sep 2022.