NCT00148460

Brief Summary

The objective of this trial was to compare the efficacy and safety of a single bolus of TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

Geographic Reach
3 countries

18 active sites

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

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

First QC Date

September 7, 2005

Last Update Submit

October 28, 2013

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery (IRA)

    at 90 minutes after the start of thrombolytic treatment

Secondary Outcomes (5)

  • Infarct-related artery patency

    at 90 minutes

  • The percentage of subjects with ST-segment resolution

    at 60 and 180 minutes

  • Mortality

    30-days

  • Safety

  • The effects of TNK-tPA on coagulation and fibrinogenolysis (at selected clinical sites)

Interventions

TNK-tPADRUG
rt-PADRUG

Eligibility Criteria

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

You may qualify if:

  • Age \>= 18 and \<= 75 years.
  • Asian origin.
  • Ischemic discomfort \>= 30 minutes in duration.
  • Onset of acute myocardial infarction (AMI) symptoms within 6 hours prior to randomization.
  • A twelve lead electrocardiogram (ECG) with one of the following:
  • ST segment elevation \>= 0.1 mV in two or more limb leads; or
  • \>= 0.2 mV in two or more contiguous precordial leads indicative of AMI.
  • Ability to give informed consent.

You may not qualify if:

  • Previous coronary artery bypass grafting (CABG) surgery.
  • Cardiogenic shock (e.g. systolic blood pressure \[SBP\] \< 90 mmHg).
  • Systolic blood pressure (SBP) \>= 180 mmHg and/or diastolic blood pressure (DBP) \>= 110 mmHg during current admission on one reliable measurement prior to randomization.
  • Inability to undergo cardiac catheterization.
  • Significant bleeding disorder either at present or within the past 6 months.
  • Major surgery, biopsy of a parenchymal organ, or significant trauma within 3 months.
  • Any minor head trauma and/or any other trauma that occurred after onset of current myocardial infarction.
  • Use of heparin, GPIIb/IIIa antagonists or other anticoagulants within the last 2 weeks.
  • Any known history of stroke or transient ischemic attack or central nervous system structural damage (i.e. neoplasm, aneurysm, intracranial surgery).
  • Prolonged cardiopulmonary resuscitation (\> 10 minutes) within 2 weeks.
  • Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing potential must have had a negative pregnancy test and must have used a medically accepted method of birth control (i.e. uterine device, surgical sterilisation, progestogens alone).
  • Previous treatment with TNK-tPA (tenecteplase).
  • Inability to follow protocol and comply with follow-up.
  • Drug abuse within the last year.
  • Participation in another clinical trial within the previous 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Beijing An Zhen Hospital

Beijing, 100029, China

Location

Beijing University

Beijing, 100044, China

Location

Beijing Friendship Hospital

Beijing, 100050, China

Location

Beijing Xuan Wu Hospital

Beijing, 100050, China

Location

Bejing Tongren Hospital

Beijing, 100730, China

Location

Center Hospital of Dalian

Dalian, 116033, China

Location

Center Hospital of Jinan

Jinan, 250013, China

Location

Fudan University

Shanghai, 200032, China

Location

People's Hospital of Liaoning Province

Shenyang, 110015, China

Location

The University of Hong Kong, Cardiology Division

Hong Kong, Hong Kong

Location

Dongsan Medical Center

Jung-Ku, 700711, South Korea

Location

Chunnam University Hospital

Kwangju, 501757, South Korea

Location

Dong-A University Hospital

Pusan, 602715, South Korea

Location

Seoul National University Hospital

Seoul, 100744, South Korea

Location

Yonsei University Severance Hospital

Seoul, 120752, South Korea

Location

Seoul Joongang Hospital

Seoul, 138736, South Korea

Location

A-Jou University Hospital

Suwon, 443721, South Korea

Location

Wonju Christian Hospital (Yonsei University Hosp)

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

TNK-tissue plasminogen activator

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim Shanghai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

March 1, 2001

Study Completion

February 1, 2006

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

HK(1)CN(9)KR(8)