NCT00306228

Brief Summary

The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents. The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
436

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

March 21, 2006

Last Update Submit

September 25, 2009

Conditions

Myocardial Infarction

Keywords

ST elevation acute myocardial infarctionThrombolysisEarly routine percutaneous coronary interventiontirofibanpaclitaxel

Outcome Measures

Primary Outcomes (2)

  • to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis

    12 months

  • to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI

    24 hours

Secondary Outcomes (6)

  • to determine the safety of paclitaxel eluting stent in terms of rate of complications, and particularly acute and subacute total occlusion.

    12 months

  • to determine the interaction of paclitaxel eluting stent and the complicated myocardial infarction lesion in terms of reduction of intimal proliferation as evaluated by quantitative coronary angiography

    12 months

  • to determine the efficacy of paclitaxel eluting stent in different subgroups of patients: diabetics, small vessel (<2.5 mm), long lesion (>15 mm), gender, and tirofiban use.

    12 months

  • to determine the efficacy and safety of full dose fibrinolytic therapy plus delayed tirofiban compared to fibrinolytic therapy alone in different subgroups: diabetics and the elderly

    30 days

  • to determine the efficacy of use of tirofiban in relation to time to fibrinolytic therapy and time to mechanical revascularization.

    24 hours

  • +1 more secondary outcomes

Study Arms (4)

bare-metal stent without tirofiban

ACTIVE COMPARATOR

implantation of a bare-metal stent with no tirofiban infusion after fibrinolysis

Procedure: Postfibrinolysis percutaneous coronary intervention

bare-metal stent with tirofiban

ACTIVE COMPARATOR

implantation of a bare-metal stent with tirofiban infusion after fibrinolysis

Procedure: Postfibrinolysis percutaneous coronary intervention

paclitaxel-eluting stent without tirofiban

ACTIVE COMPARATOR

implantation of a paclitaxel eluting-stent with no tirofiban after fibrinolysis

Procedure: Postfibrinolysis percutaneous coronary intervention

paclitaxel-eluting stent with tirofiban

ACTIVE COMPARATOR

implantation of a paclitaxel eluting-stent with tirofiban infusion after fibrinolysis

Procedure: Postfibrinolysis percutaneous coronary intervention

Interventions

Postfibrinolysis percutaneous coronary interventionPROCEDURE

implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis

Also known as: Express stents (Boston Scientific, Natick, Massachusetts)
bare-metal stent without tirofiban

Eligibility Criteria

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

You may qualify if:

  • Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment:
  • Age \>18 years.
  • Chest discomfort \>30 minutes with no response to nitroglycerin.
  • Time from the onset of symptoms to randomization \< 12 hours.
  • ST segment elevation \> 1 mm in two or more limb leads or 2 mm in two or more contiguous precordial leads or non-diagnostic ECG (left bundle branch block or pacemaker rhythm) with classic symptoms.
  • Killip class \> 3.
  • Written informed consent will be obtained.

You may not qualify if:

  • Patients presenting with any of the following will not be included in the study.
  • Cardiogenic shock defined as a systolic blood pressure \<90 mm Hg without response to fluid administration or \<100 mmHg in patients with supportive treatment and no bradycardia.
  • Suspected mechanical complications of acute myocardial infarction.
  • Previous CABG.
  • Non-cardiac disease that is likely to jeopardize the planned termination of the study.
  • Woman of childbearing potential unless a negative pregnant test.
  • Active bleeding and recent (within 2 weeks) surgery that contraindicate the use of heparin, tirofiban, or platelet aggregation inhibitors.
  • Contraindications for thrombolytic use.
  • previous hemorrhagic stroke at any time
  • history of prior non-hemorrhagic cerebrovascular accident within 12 months
  • intracerebral neoplasia
  • active internal bleeding
  • suspected aortic dissection
  • Uncontrolled hypertension \>180/110 in several measurements
  • any other known intracerebral pathology not covered in contraindications
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47005, Spain

Location

Related Publications (1)

  • Sanchez PL, Gimeno F, Ancillo P, Sanz JJ, Alonso-Briales JH, Bosa F, Santos I, Sanchis J, Bethencourt A, Lopez-Messa J, de Prado AP, Alonso JJ, San Roman JA, Fernandez-Aviles F. Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial. Circ Cardiovasc Interv. 2010 Aug;3(4):297-307. doi: 10.1161/CIRCINTERVENTIONS.109.920868.

    PMID: 20716757DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Francisco Fernandez-Aviles, MD, PhD

    ICICOR, Hospital Clínico Universitario Valladolid, Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

October 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2009

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

ES(1)