Role of Tirofiban and the Paclitaxel Eluting Stent in Postfibrinolysis Angioplasty (GRACIA3)

This study has been completed.
Sponsor:
Collaborators:
Spanish Ministry of Health.
Spanish Ministry of Science and Innovation
Information provided by:
GRACIA Group
ClinicalTrials.gov Identifier:
NCT00306228
First received: March 21, 2006
Last updated: September 25, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Procedure: Postfibrinolysis percutaneous coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Trial to Evaluate the Role of Paclitaxel Eluting Stent and Tirofiban to Improve the Results of Facilitated PCI in the Treatment of Acute ST- Segment Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by GRACIA Group:

Primary Outcome Measures:
  • to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to determine the safety of paclitaxel eluting stent in terms of rate of complications, and particularly acute and subacute total occlusion. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • to determine the efficacy of use of tirofiban in relation to time to fibrinolytic therapy and time to mechanical revascularization. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • to determine possible interactions between the paclitaxel eluting stent and tirofiban in terms of restenosis or acute and subacute total occlusion following coronary stenting. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 436
Study Start Date: October 2004
Study Completion Date: January 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bare-metal stent without tirofiban
implantation of a bare-metal stent with no tirofiban infusion after fibrinolysis
Procedure: Postfibrinolysis percutaneous coronary intervention
implantation of a bare-metal stent with no infusion of tirofiban 120 minutes after fibrinolysis
Other Name: Express stents (Boston Scientific, Natick, Massachusetts)
Active Comparator: bare-metal stent with tirofiban
implantation of a bare-metal stent with tirofiban infusion after fibrinolysis
Procedure: Postfibrinolysis percutaneous coronary intervention
implantation of a bare-metal stent with infusion of tirofiban 120 minutes after fibrinolysis
Other Name: Express stents (Boston Scientific, Natick, Massachusetts)
Active Comparator: paclitaxel-eluting stent without tirofiban
implantation of a paclitaxel eluting-stent with no tirofiban after fibrinolysis
Procedure: Postfibrinolysis percutaneous coronary intervention
implantation of a paclitaxel eluting-stent with no infusion of tirofiban 120 minutes after fibrinolysis
Other Name: TAXUS stents (Boston Scientific)
Active Comparator: paclitaxel-eluting stent with tirofiban
implantation of a paclitaxel eluting-stent with tirofiban infusion after fibrinolysis
Procedure: Postfibrinolysis percutaneous coronary intervention
implantation of a paclitaxel eluting-stent with infusion of tirofiban 120 minutes after fibrinolysis
Other Name: TAXUS stents (Boston Scientific)

Detailed Description:

The primary objectives of this study are: first to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis, and second to determine the effect of tirofiban administered prior to percutaneous coronary intervention (PCI) but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI.

Methods: This is a phased 4, 2x2 randomised, open, multicenter, clinical study. Patients will be randomised 1:1:1:1 to four groups: a) paclitaxel eluting stent with tirofiban, b) paclitaxel eluting stent without tirofiban, c) bare stent with tirofiban and d) bare stent without tirofiban. A total of approximately 436 patients, with <12 hours STEMI will be enrolled. All patients will be initially treated with tenecteplase (TNK) and enoxaparin. Tirofiban will start 120 minutes after tenecteplase administration in those patients randomised to tirofiban. Cardiac catheterization will be performed within the first 3-12 hours after the study inclusion and stenting on the culprit artery, with the randomised paclitaxel or bare stent, will be performed.

The efficacy of these strategies will be measured in terms of: 1) binary restenosis, defined as >50% diameter stenosis and segment analysis including the stented segment as well as their margins, 5 mm proximal and distal to the stent at 9-12 months follow-up and, 2) the assessment of the epicardial and myocardial perfusion (%TIMI 3, CTFC, CFR-CTFC, TMP y DSA-TMP and the analysis of the normalization of the ST segment at 90 minutes, 3, 6, 12 and 24 hours after thrombolysis).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with ST-segment elevation acute myocardial infarction with all of the following criteria will be eligible for enrollment:

  1. Age >18 years.
  2. Chest discomfort >30 minutes with no response to nitroglycerin.
  3. Time from the onset of symptoms to randomization < 12 hours.
  4. 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.
  5. Killip class > 3.
  6. Written informed consent will be obtained.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study.

  1. 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.
  2. Suspected mechanical complications of acute myocardial infarction.
  3. Previous CABG.
  4. Non-cardiac disease that is likely to jeopardize the planned termination of the study.
  5. Woman of childbearing potential unless a negative pregnant test.
  6. Active bleeding and recent (within 2 weeks) surgery that contraindicate the use of heparin, tirofiban, or platelet aggregation inhibitors.
  7. 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
    • Current use of anticoagulants or heparin use within 8 hours
    • known bleeding diathesis
    • recent trauma (< 4 weeks), including head trauma or traumatic or prolonged (>10 minutes) CPR or recent major surgery or biopsy (<8 weeks)
    • noncompressible vascular punctures
    • recent (< 4 weeks) internal bleeding
    • pregnancy
    • active peptic ulcer
  8. History of hypersensitivity to aspirin, ticlopidine, clopidogrel, heparin, tirofiban and stainless steel.
  9. Known renal failure, creatinine >2,5 mg/dL.
  10. Known impaired hepatic function that contraindicates the use of clopidogrel.
  11. Known thrombocytopenia (100.000).
  12. Participation in other trial.
  13. Known multivessel disease identified as no suitable for revascularization.
  14. Known peripheral vascular disease that difficult cardiac catheterization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306228

Locations
Spain
Instituto de Ciencias del Corazón (ICICOR). Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47005
Sponsors and Collaborators
GRACIA Group
Spanish Ministry of Health.
Spanish Ministry of Science and Innovation
Investigators
Study Chair: Francisco Fernandez-Aviles, MD, PhD ICICOR, Hospital Clínico Universitario Valladolid, Spain
  More Information

No publications provided by GRACIA Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco Fernandez Aviles, Hospital General Universitario Gregorio Maranon
ClinicalTrials.gov Identifier: NCT00306228     History of Changes
Other Study ID Numbers: GRACIA 3
Study First Received: March 21, 2006
Last Updated: September 25, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GRACIA Group:
ST elevation acute myocardial infarction
Thrombolysis
Early routine percutaneous coronary intervention
tirofiban
paclitaxel

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Paclitaxel
Tirofiban
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014