Myocardial InfarctionPhase 4LIPSIA-NSTEMINCT00402675
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI
A Phase 4 study testing Timing of percutaneous coronary intervention in people with Myocardial Infarction, run by University of Leipzig at 5 sites in Germany.
Trial summary
In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear. Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Timing of percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2006to Jan 2010
- Phase
- Phase 4
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms:
- Instable angina pectoris:
- Angina at rest < 24 hours
- new onset worsening angina within the last weeks with angina at very low threshold < 24 h
- Troponin T:
- Troponin T-elevation ≥ 0,03 μg/l
- Informed consent
Who cannot join
- Age < 18 years
- Age > 90 years
- STEMI
- Hemodynamic instability
- Cardiogenic shock
- Warfarin therapy
Show all 12Show fewer
- Contraindications for GpIIb/IIIa-inhibitors
- life expectancy < 6 months
- known high bleeding risk
- Pregnancy
- Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation
- No informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinikum Links der Weser
Bremen, 28277
Städt. Klinikum St. Georg
Leipzig, 04129
University of Leipzig - Heart Center
Leipzig, 04289
University of Leipzig
Leipzig, 12103
Krankenhaus der Barmherzigen Brüder
Regensburg, 93049
About this study
Official title: Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.
Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.
The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.
Read the detailed description
In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (< 2,5 hours after randomization) similar to ST-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-ST-elevation myocardial infarction.
All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.
- Conditions
- Myocardial Infarction
- Being tested
- Timing of percutaneous coronary intervention
- Keywords
- NSTEMI, infarction, treatment, percutaneous coronary intervention, non-ST-elevation myocardial infarction
- Medical subject headings
- Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of percutaneous coronary interventionProcedure or surgery
Immediate, early or selective invasive angiography
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Active comparator | Patients with NSTEMI undergo immediate invasive angiography (< 2 hours) Receives: Procedure: Timing of percutaneous coronary intervention |
| Early Intervention | Active comparator | Patients with NSTEMI undergo early invasive angiography (12-48 hours) Receives: Procedure: Timing of percutaneous coronary intervention |
| Selective invasive angiography | Active comparator | Patients with NSTEMI undergo selective invasive angiography Receives: Procedure: Timing of percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak creatine kinase- MB level
Measured: 5 days
Secondary outcomes (2)
Major bleeding complications (GUSTO definition)
Measured: 30 days
Composite: death, re-myocardial infarction, recurrent unstable angina
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Holger Thiele, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402675
- Sponsor's protocol ID
- Leipzig-4
- Acronym
- LIPSIA-NSTEMI
- Status last verified
- Nov 2006
- First submitted
- 20 Nov 2006
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thiele H, Rach J, Klein N, Pfeiffer D, Hartmann A, Hambrecht R, Sick P, Eitel I, Desch S, Schuler G; LIPSIA-NSTEMI Trial Group. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J. 2012 Aug;33(16):2035-43. doi: 10.1093/eurheartj/ehr418. Epub 2011 Nov 21.
PubMed 22108830
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
- ClinicalTrials.gov ID
- NCT00402675
- Acronym / sponsor ID
- LIPSIA-NSTEMI / Leipzig-4
- Conditions
- Myocardial Infarction
- Keywords
- NSTEMI, infarction, treatment, percutaneous coronary intervention, non-ST-elevation myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Nov 2006 (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.
In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.
Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.
The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.
Detailed description
In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (< 2,5 hours after randomization) similar to ST-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-ST-elevation myocardial infarction.
All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Active comparator | Procedure: Timing of percutaneous coronary interventionPatients with NSTEMI undergo immediate invasive angiography (< 2 hours) |
| Early Intervention | Active comparator | Procedure: Timing of percutaneous coronary interventionPatients with NSTEMI undergo early invasive angiography (12-48 hours) |
| Selective invasive angiography | Active comparator | Procedure: Timing of percutaneous coronary interventionPatients with NSTEMI undergo selective invasive angiography |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical symptoms:
- Troponin T:
- Troponin T-elevation ≥ 0,03 μg/l
- Informed consent
Key exclusion criteria (12 listed)
- Age < 18 years
- Age > 90 years
- STEMI
- Hemodynamic instability
- Cardiogenic shock
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 |
|---|---|---|
| Timing of percutaneous coronary interventionImmediate, early or selective invasive angiography | Procedure or surgery | Early Intervention, Immediate Intervention, Selective invasive angiography |
Primary outcome
peak creatine kinase- MB level
Time frame: 5 days
2 secondary outcomes
Major bleeding complications (GUSTO definition)
Time frame: 30 days
Composite: death, re-myocardial infarction, recurrent unstable angina
Time frame: 6 months
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 5 Jan 2010.
- Derived from this study: PubMed 22108830Thiele H, Rach J, Klein N, Pfeiffer D, Hartmann A, Hambrecht R, Sick P, Eitel I, Desch S, Schuler G; LIPSIA-NSTEMI Trial Group. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J. 2012 Aug;33(16):2035-43. doi: 10.1093/eurheartj/ehr418. Epub 2011 Nov 21.
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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.
Holger Thiele principal investigator
Heart Center Leipzig - University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timing of percutaneous coronary intervention in people with Myocardial Infarction, run by University of Leipzig at 5 sites in Germany.
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 7 inclusion and 12 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 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
peak creatine kinase- MB level (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402675, which also lists 1 linked publication.
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 5 Jan 2010.