Myocardial InfarctionPhase 4TOLEDO1NCT01383785
Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab
A Phase 4 study testing Intracoronary direct injection, Intracoronary and distal injection by aspiration device and Intracoronary distal injection by aspiration catheter device in people with Myocardial Infarction and Occlusive Thrombus, run by Hospital Virgen de la Salud at 1 site in Spain.
Trial summary
Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Occlusive Thrombus
- What is being tested?
- Intracoronary direct injection, Intracoronary and distal injection by aspiration device and Intracoronary distal injection by aspiration catheter device
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2009to Dec 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myocardial infarction patients between 3 and 12 hours after symptoms onset
Who cannot join
- Hemodynamic instability
- TIMI flow 2 or 3
- Life expectance less than 6 months
- Contraindication to AAS, clopidogrel or abciximab
- Severe tortuosity of occluded vessel
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Virgen de la Salud
Toledo, Toledo, 45004
Jose Moreu, pHD,md, +34 925 269 188, jmoreu@sescam.jccm.es
Tomas Canton, MD
About this study
Official title: Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter
Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.
Read the detailed description
There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality.
- Conditions
- Myocardial Infarction, Occlusive Thrombus
- Being tested
- Intracoronary direct injection, Intracoronary and distal injection by aspiration device, Intracoronary distal injection by aspiration catheter device
- Keywords
- Primary PTCA, Thrombus Aspiration Catheter, Intracoronary Abciximab
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary direct injectionOther
Also called Abciximab, thrombus aspiration catheter
Abciximab bolus dosage: 0,125 mg/kg.
Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory.
Intracoronary and distal injection by aspiration deviceOther
Also called Abciximab, thrombus aspiration catheter
Abciximab bolus dosage: 0,125 mg/kg.
Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C.
Intracoronary distal injection by aspiration catheter deviceOther
Also called Abciximab, thrombus aspiration catheter
Abciximab bolus dosage: 0,125 mg/kg.
Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | Intracoronary full bolus dose of abciximab proximal to thrombus occlusion Receives: Other: Intracoronary direct injection |
| GROUP B | Experimental | Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter Receives: Other: Intracoronary and distal injection by aspiration device |
| GROUP C | Experimental | Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter Receives: Other: Intracoronary distal injection by aspiration catheter device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
Infarct size quantified by MR
Measured: Between 2 and 9 days after primary ptca
Secondary outcomes (1)
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Cardiac mortality, reinfarction, new revascularization, and stroke
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startNov 2009
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Virgen de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.Moreu, Hospital Virgen de la Salud
- Investigators
- Jose Moreu, Phd,MD, Principal investigator, Hospital Virgen de la Salud. Toledo. SpainLuis Rodriguez-Padial, Phd MD, Study director, Hospital Virgen de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383785
- Sponsor's protocol ID
- PI-2008/52
- Acronym
- TOLEDO1
- Status last verified
- Feb 2012
- First submitted
- 22 Jun 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
PubMed 19004841Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.
PubMed 18256391Vetrovec GW. Improving reperfusion in patients with myocardial infarction. N Engl J Med. 2008 Feb 7;358(6):634-7. doi: 10.1056/NEJMe0708910. No abstract available.
PubMed 18256399Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.
PubMed 18559698Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.
PubMed 18617066
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter
- ClinicalTrials.gov ID
- NCT01383785
- Acronym / sponsor ID
- TOLEDO1 / PI-2008/52
- Conditions
- Myocardial Infarction, Occlusive Thrombus
- Keywords
- Primary PTCA, Thrombus Aspiration Catheter, Intracoronary Abciximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Hospital Virgen de la SaludUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Jun 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.
Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.
Detailed description
There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Other: Intracoronary direct injectionIntracoronary full bolus dose of abciximab proximal to thrombus occlusion |
| GROUP B | Experimental | Other: Intracoronary and distal injection by aspiration deviceHalf bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter |
| GROUP C | Experimental | Other: Intracoronary distal injection by aspiration catheter deviceDistal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myocardial infarction patients between 3 and 12 hours after symptoms onset
Key exclusion criteria (5 listed)
- Hemodynamic instability
- TIMI flow 2 or 3
- Life expectance less than 6 months
- Contraindication to AAS, clopidogrel or abciximab
- Severe tortuosity of occluded vessel
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 |
|---|---|---|
| Intracoronary direct injectionAlso: Abciximab, thrombus aspiration catheterAbciximab bolus dosage: 0,125 mg/kg. Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory. | Other | GROUP A |
| Intracoronary and distal injection by aspiration deviceAlso: Abciximab, thrombus aspiration catheterAbciximab bolus dosage: 0,125 mg/kg. Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C. | Other | GROUP B |
| Intracoronary distal injection by aspiration catheter deviceAlso: Abciximab, thrombus aspiration catheterAbciximab bolus dosage: 0,125 mg/kg. Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter. | Other | GROUP C |
Primary outcome
Infarct size
Time frame: Between 2 and 9 days after primary ptca
Infarct size quantified by MR
1 secondary outcome
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Background: PubMed 19004841Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
- Background: PubMed 18256391Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.
- Background: PubMed 18256399Vetrovec GW. Improving reperfusion in patients with myocardial infarction. N Engl J Med. 2008 Feb 7;358(6):634-7. doi: 10.1056/NEJMe0708910. No abstract available.
- Background: PubMed 18559698Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.
- Background: PubMed 18617066Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.
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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.
Jose Moreu, Phd,MD principal investigator
Hospital Virgen de la Salud. Toledo. Spain
Luis Rodriguez-Padial, Phd MD study director
Hospital Virgen de la Salud
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 Intracoronary direct injection, Intracoronary and distal injection by aspiration device and Intracoronary distal injection by aspiration catheter device in people with Myocardial Infarction and Occlusive Thrombus, run by Hospital Virgen de la Salud at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Feb 2012. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Moreu, MD,PhD (+34 925 269 188, jmoreu@sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size (time frame: Between 2 and 9 days after primary ptca). 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 NCT01383785, which also lists 5 linked publications.
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 22 Feb 2012.