search
Back to results

Intracoronary Tirofiban on No-Reflow Phenomena

Primary Purpose

No-Reflow Phenomenon

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tirofiban
Placebo
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for No-Reflow Phenomenon focused on measuring No-reflow phenomenon, tirofiban, intracoronary

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with ST-elevated myocardial infarction who developed no-reflow phenomena

Exclusion Criteria:

  • Treatment with thrombolytic drugs in the previous 24 hours
  • Known malignancy
  • Pain to balloon time >6 hours
  • Uncontrolled hypertension (>180/110 mmHg)
  • Bleeding diathesis
  • Thrombocytopenia
  • End-stage liver disease
  • Cardiogenic shock
  • Renal failure
  • Life expectancy of less than 1 year
  • Contraindication for the use of tirofiban.

Sites / Locations

  • Erciyes University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tirofiban group

Placebo group

Arm Description

If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary tirofiban (25 µgr/kg) was administered via the guiding catheter to the infarct related artery

If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary serum physiologic as placebo was administered via the guiding catheter to the infarct related artery

Outcomes

Primary Outcome Measures

in-hospital mortality
Non-fatal myocardial infarction
in-stent thrombosis

Secondary Outcome Measures

Full Information

First Posted
January 30, 2014
Last Updated
February 1, 2014
Sponsor
TC Erciyes University
search

1. Study Identification

Unique Protocol Identification Number
NCT02054000
Brief Title
Intracoronary Tirofiban on No-Reflow Phenomena
Official Title
Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

5. Study Description

Brief Summary
The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).
Detailed Description
The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct related arterial (IRA) flow related to better ventricular performance and lower mortality rate in patients with STEMI. In addition, no-reflow phenomena may limit the benefits of re-canalization of the IRA. In recent years, many mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI. Although current guidelines recommend that small molecule GPI should be administered as an upstream bolus followed by a continuous infusion in patients with STEMI, changes in clinical practice may obviate the need for GPI dosage or routes in current practice. Previous studies have shown that intravenous and intracoronary administration of GPI improve the prognosis and significantly reduce mortality in patients with STEMI. Recently, the Ongoing Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial found that the use of tirofiban started during the pre-hospital phase as upstream therapy for primary percutaneous coronary intervention (PCI) and continued for up to 18 hours infusion after the procedure showed an improvement in the markers of reperfusion. Additionally, a reduction was demonstrated in the death in recurrent myocardial infarction in urgent target vessel revascularization and thrombotic bailout. However, in the current literature there are insufficient data regarding the role of intracoronary administration of GPI inhibitors in patients with STEMI who developed the no-reflow phenomenon. The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No-Reflow Phenomenon
Keywords
No-reflow phenomenon, tirofiban, intracoronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirofiban group
Arm Type
Active Comparator
Arm Description
If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary tirofiban (25 µgr/kg) was administered via the guiding catheter to the infarct related artery
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
If thrombolysis in myocardial infarction flow <3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary serum physiologic as placebo was administered via the guiding catheter to the infarct related artery
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Other Intervention Name(s)
Glycoprotein IIb/IIIa inhibitor
Intervention Description
Intracoronary administering of Tirofiban
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intracoronary serum physiologic
Primary Outcome Measure Information:
Title
in-hospital mortality
Time Frame
up to 8 days
Title
Non-fatal myocardial infarction
Time Frame
up to 8 days
Title
in-stent thrombosis
Time Frame
up to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients with ST-elevated myocardial infarction who developed no-reflow phenomena Exclusion Criteria: Treatment with thrombolytic drugs in the previous 24 hours Known malignancy Pain to balloon time >6 hours Uncontrolled hypertension (>180/110 mmHg) Bleeding diathesis Thrombocytopenia End-stage liver disease Cardiogenic shock Renal failure Life expectancy of less than 1 year Contraindication for the use of tirofiban.
Facility Information:
Facility Name
Erciyes University School of Medicine
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Intracoronary Tirofiban on No-Reflow Phenomena

We'll reach out to this number within 24 hrs