NCT01383785

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

2.7 years

First QC Date

June 22, 2011

Last Update Submit

February 20, 2012

Conditions

Myocardial InfarctionOcclusive Thrombus

Keywords

Primary PTCAThrombus Aspiration CatheterIntracoronary Abciximab

Outcome Measures

Primary Outcomes (1)

  • Infarct size

    Infarct size quantified by MR

    Between 2 and 9 days after primary ptca

Secondary Outcomes (1)

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    6 months

Study Arms (3)

GROUP A

ACTIVE COMPARATOR

Intracoronary full bolus dose of abciximab proximal to thrombus occlusion

Other: Intracoronary direct injection

GROUP B

EXPERIMENTAL

Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter

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

Other: Intracoronary distal injection by aspiration catheter device

Interventions

Intracoronary direct injectionOTHER

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.

Also known as: Abciximab, thrombus aspiration catheter
GROUP A
Intracoronary and distal injection by aspiration deviceOTHER

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.

Also known as: Abciximab, thrombus aspiration catheter
GROUP B
Intracoronary distal injection by aspiration catheter deviceOTHER

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.

Also known as: Abciximab, thrombus aspiration catheter
GROUP C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myocardial infarction patients between 3 and 12 hours after symptoms onset

You may not qualify if:

  • Hemodynamic instability
  • TIMI flow 2 or 3
  • Life expectance less than 6 months
  • Contraindication to AAS, clopidogrel or abciximab
  • Severe tortuosity of occluded vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen de la Salud

Toledo, Toledo, 45004, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 19004841BACKGROUND

  • Svilaas 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.

    PMID: 18256391BACKGROUND

  • Vetrovec 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.

    PMID: 18256399BACKGROUND

  • Thiele 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.

    PMID: 18559698BACKGROUND

  • Nijveldt 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.

    PMID: 18617066BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Jose Moreu, Phd,MD

    Hospital Virgen de la Salud. Toledo. Spain

    PRINCIPAL INVESTIGATOR

  • Luis Rodriguez-Padial, Phd MD

    Hospital Virgen de la Salud

    STUDY DIRECTOR

Central Study Contacts

Jose Moreu, MD,PhD

CONTACT

+34 925 269 188jmoreu@sescam.jccm.es

Fernando Pajin, MD

CONTACT

+34 925 269 188lfpajinv@sescam.jccm.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director catheterization laboratory

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 28, 2011

Study Start

November 1, 2009

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

ES(1)