Myocardial InfarctionPhase 3NCT00148460
Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of Rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction
A Phase 3 study testing TNK-tPA and rt-PA in people with Myocardial Infarction, run by Boehringer Ingelheim at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- TNK-tPA and rt-PA
- How many people
- 270 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Mar 2001to Feb 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
China9 sites
Beijing An Zhen Hospital
Beijing, 100029
Beijing University
Beijing, 100044
Beijing Friendship Hospital
Beijing, 100050
Beijing Xuan Wu Hospital
Beijing, 100050
Bejing Tongren Hospital
Beijing, 100730
Center Hospital of Dalian
Dalian, 116033
Center Hospital of Jinan
Jinan, 250013
Fudan University
Shanghai, 200032
People's Hospital of Liaoning Province
Shenyang, 110015
South Korea8 sites
Dongsan Medical Center
Jung-Ku, 700711
Chunnam University Hospital
Kwangju, 501757
Dong-A University Hospital
Pusan, 602715
Seoul National University Hospital
Seoul, 100744
Yonsei University Severance Hospital
Seoul, 120752
Seoul Joongang Hospital
Seoul, 138736
A-Jou University Hospital
Suwon, 443721
Wonju Christian Hospital (Yonsei University Hosp)
Wŏnju
About this study
Official title: A Randomised, Open-label, Multi-center, Angiographic Trial to Compare the Efficacy and Safety of Single Bolus of Tenecteplase (Metalyse®) With Accelerated Infusion of Alteplase in Asian Patients With Acute Myocardial Infarction
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.
Read the detailed description
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy and safety of TNK-tPA (tenecteplase, Metalyse®) with that of accelerated rt-PA (alteplase, Actilyse®) in Asian patients with AMI. The primary endpoint (TIMI 3 Flow) and the secondary endpoint (TIMI frame count) were evaluated in a blinded manner in the core laboratory.
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. TNK-tPA or accelerated rt-PA).
The study period totaled 30-37 days and included baseline, randomisation, study drug administration, in-hospital follow-up and thirty-day follow-up.
Coronary angiography was performed at 90 minutes after the start of study drug administration. 12-lead electrocardiograms (ECGs) were obtained before randomization, between 60 to 75 minutes and 180 ± 15 minutes after the start of study drug administration, and at hospital discharge.
If the patient showed rapid and progressive hemodynamic deterioration before 90 minutes, rescue PTCA or other appropriate interventions should be performed at the discretion of the treating physician.
Following the analysis of TIMI flow and frame count at each study center, the results were carefully recorded on the CRFs. This data was stored on a compact disk or a film and labeled with the subject's study I.D. number. It was then sent with the summary worksheets and ECGs to the Angiographic Core Laboratory located at the Leuven Coordinating Center (LCC) of the University Hospital Gasthuisberg (Leuven, Belgium) for central evaluations.
Study Hypothesis:
The null hypothesis tested was that there was no difference between the two treatment groups: TNK-tPA (Tenecteplase, Metalyse®) and accelerated rt-PA (Actilyse®), against the alternative that there was a difference.
Comparison(s):
The primary endpoint of the study was TIMI 3 flow at 90 minutes after start of thrombolytic therapy, angiograms were evaluated in a blinded manner in a core laboratory.
- Conditions
- Myocardial Infarction
- Being tested
- TNK-tPA, rt-PA
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNK-tPADrug
rt-PADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery (IRA)
Measured: at 90 minutes after the start of thrombolytic treatment
Secondary outcomes (5)
Infarct-related artery patency
Measured: at 90 minutes
The percentage of subjects with ST-segment resolution
Measured: at 60 and 180 minutes
Mortality
Measured: 30-days
Safety
The effects of TNK-tPA on coagulation and fibrinogenolysis (at selected clinical sites)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148460
- Sponsor's protocol ID
- 1123.8
- Status last verified
- Oct 2013
- First submitted
- 7 Sep 2005
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Multi-center, Angiographic Trial to Compare the Efficacy and Safety of Single Bolus of Tenecteplase (Metalyse®) With Accelerated Infusion of Alteplase in Asian Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00148460
- Acronym / sponsor ID
- 1123.8
- Conditions
- Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Study completion
- Feb 2006
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy and safety of TNK-tPA (tenecteplase, Metalyse®) with that of accelerated rt-PA (alteplase, Actilyse®) in Asian patients with AMI. The primary endpoint (TIMI 3 Flow) and the secondary endpoint (TIMI frame count) were evaluated in a blinded manner in the core laboratory.
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. TNK-tPA or accelerated rt-PA).
The study period totaled 30-37 days and included baseline, randomisation, study drug administration, in-hospital follow-up and thirty-day follow-up.
Coronary angiography was performed at 90 minutes after the start of study drug administration. 12-lead electrocardiograms (ECGs) were obtained before randomization, between 60 to 75 minutes and 180 ± 15 minutes after the start of study drug administration, and at hospital discharge.
If the patient showed rapid and progressive hemodynamic deterioration before 90 minutes, rescue PTCA or other appropriate interventions should be performed at the discretion of the treating physician.
Following the analysis of TIMI flow and frame count at each study center, the results were carefully recorded on the CRFs. This data was stored on a compact disk or a film and labeled with the subject's study I.D. number. It was then sent with the summary worksheets and ECGs to the Angiographic Core Laboratory located at the Leuven Coordinating Center (LCC) of the University Hospital Gasthuisberg (Leuven, Belgium) for central evaluations.
Study Hypothesis:
The null hypothesis tested was that there was no difference between the two treatment groups: TNK-tPA (Tenecteplase, Metalyse®) and accelerated rt-PA (Actilyse®), against the alternative that there was a difference.
Comparison(s):
The primary endpoint of the study was TIMI 3 flow at 90 minutes after start of thrombolytic therapy, angiograms were evaluated in a blinded manner in a core laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNK-tPA | Drug | – |
| rt-PA | Drug | – |
Primary outcome
The percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery (IRA)
Time frame: at 90 minutes after the start of thrombolytic treatment
5 secondary outcomes
Infarct-related artery patency
Time frame: at 90 minutes
The percentage of subjects with ST-segment resolution
Time frame: at 60 and 180 minutes
Mortality
Time frame: 30-days
Safety
The effects of TNK-tPA on coagulation and fibrinogenolysis (at selected clinical sites)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim Shanghai
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TNK-tPA and rt-PA in people with Myocardial Infarction, run by Boehringer Ingelheim at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China, South Korea, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery (IRA) (time frame: at 90 minutes after the start of thrombolytic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.