Acute Chest SyndromePhase 3GRAY-ZONENCT03820466
Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin
A Phase 3 study testing Aspirin and Atorvastatin in people with Acute Chest Syndrome, run by Dr. med. Mahir Karakas at 7 sites in Germany.
Trial summary
The study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with symptoms suggestive for ACS, and elevated high-sensitivity troponin values Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Chest Syndrome
- What is being tested?
- Aspirin and Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 7 sitesGermany
- Study dates
- 21 Feb 2020to 7 Apr 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with symptoms suggestive for ACS presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)
- Patient has at least one elevated high-sensitivity troponin I or T value
- Chest pain is classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
- At least 50 years of age
Who cannot join
- Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation)
- Indication for anti-lipid therapy
- Any evidence of an acute myocardial necrosis (e.g imaging evidence of new regional wall motion abnormality, or significant ST-segment-T wave (ST-T) changes in ECG)
- Untreated clinically significant CAD requiring revascularization
- Hemoglobin value below 8 mg/d, and/or creatinine kinase ≥3 times ULN, and/or AST or ALT ≥3 times ULN
- Active malignancy of any organ system, treated or untreated. Subjects have to be in remission for at least 36 months to be eligible.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
University of Berlin, Campus Benjamin-Franklin
Berlin, 12203
Asklepios Harz-Hospital Goslar
Goslar, 38642
University Heart Center Hamburg
Hamburg, 20246
University of Heidelberg
Heidelberg, 69120
University of Leipzig
Leipzig, 04103
Robert-Bosch-Hospital Stuttgart
Stuttgart, 70376
University of Ulm
Ulm, 89081
About this study
Official title: Investigator-initiated, Placebo-controlled, Randomized Trial to Assess the Efficacy and Safety of Platelet Inhibition and/ or Lipid Lowering in Non-ACS-patients With Elevated High-sensitivity Troponin Values
The study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with symptoms suggestive for ACS, and elevated high-sensitivity troponin values
Read the detailed description
Current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even when acute coronary syndrome (ACS) was ruled out. Most of these non-ACS-patients are discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although "positive" troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. In summary, there is an unmet need and huge potential to reduce mortality and morbidity in Chest Pain Unit patients by specific therapy. The investigators propose that platelet inhibition by Aspirin or lipid lowering by Atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. It is planned to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with symptoms suggestive for ACS, but an ACS was ruled out, will be assigned randomly to Aspirin 100 mg and/ or Atorvastatin 20 mg versus placebo (2x2 factorial design).
- Conditions
- Acute Chest Syndrome
- Being tested
- Aspirin, Atorvastatin, Placebo Aspirin, Placebo Atorvastatin
- Keywords
- Aspirin, Atorvastatin, Troponin
- Medical subject headings
- Acute Chest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetyl Salicyl Acid
Once daily application of platelet inhibiting medication
AtorvastatinDrug
Also called Statin
Once daily application of lipid lowering medication
Placebo AspirinDrug
Also called Placebo Oral Tablet
Once daily application of placebo
Placebo AtorvastatinDrug
Also called Placebo Oral Tablet
Once daily application of placebo
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin 100 mg once daily and Placebo Atorvastatin once daily Receives: Drug: Aspirin; Drug: Placebo Atorvastatin |
| Atorvastatin | Active comparator | Atorvastatin 20 mg once daily and Placebo Aspirin once daily Receives: Drug: Atorvastatin; Drug: Placebo Aspirin |
| Aspirin-Atorvastatin | Experimental | Aspirin 100 mg once daily and Atorvastatin 20 mg once daily Receives: Drug: Aspirin; Drug: Atorvastatin |
| Placebo | Placebo comparator | Placebo Aspirin once daily and Placebo Atorvastatin once daily Receives: Drug: Placebo Aspirin; Drug: Placebo Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction and/ or cardiovascular death and/ or revascularization
Time to myocardial infarction, coronary revascularization, or death, whatever comes first
Measured: Until last patient has completed 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start21 Feb 2020
- Primary completion2 Dec 2021
- Study completion7 Apr 2022
Why it stopped: insufficient recruitment due to the pandemic situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chest SyndromeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. Mahir Karakas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Mahir Karakas, MD, Study chair, University Heart Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820466
- Sponsor's protocol ID
- GRAY-ZONE
- Acronym
- GRAY-ZONE
- Status last verified
- May 2022
- First submitted
- 2 Oct 2017
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated, Placebo-controlled, Randomized Trial to Assess the Efficacy and Safety of Platelet Inhibition and/ or Lipid Lowering in Non-ACS-patients With Elevated High-sensitivity Troponin Values
- ClinicalTrials.gov ID
- NCT03820466
- Acronym / sponsor ID
- GRAY-ZONE / GRAY-ZONE
- Conditions
- Acute Chest Syndrome
- Keywords
- Aspirin, Atorvastatin, Troponin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment due to the pandemic situation
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Dr. med. Mahir KarakasUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 29 Jan 2019 (actual)
- 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 study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with symptoms suggestive for ACS, and elevated high-sensitivity troponin values
Detailed description
Current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even when acute coronary syndrome (ACS) was ruled out. Most of these non-ACS-patients are discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although "positive" troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. In summary, there is an unmet need and huge potential to reduce mortality and morbidity in Chest Pain Unit patients by specific therapy. The investigators propose that platelet inhibition by Aspirin or lipid lowering by Atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. It is planned to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with symptoms suggestive for ACS, but an ACS was ruled out, will be assigned randomly to Aspirin 100 mg and/ or Atorvastatin 20 mg versus placebo (2x2 factorial design).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin, Drug: Placebo AtorvastatinAspirin 100 mg once daily and Placebo Atorvastatin once daily |
| Atorvastatin | Active comparator | Drug: Atorvastatin, Drug: Placebo AspirinAtorvastatin 20 mg once daily and Placebo Aspirin once daily |
| Aspirin-Atorvastatin | Experimental | Drug: Aspirin, Drug: AtorvastatinAspirin 100 mg once daily and Atorvastatin 20 mg once daily |
| Placebo | Placebo comparator | Drug: Placebo Aspirin, Drug: Placebo AtorvastatinPlacebo Aspirin once daily and Placebo Atorvastatin once daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with symptoms suggestive for ACS presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)
- Patient has at least one elevated high-sensitivity troponin I or T value
- Chest pain is classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
- At least 50 years of age
Key exclusion criteria (6 listed)
- Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation)
- Indication for anti-lipid therapy
- Any evidence of an acute myocardial necrosis (e.g imaging evidence of new regional wall motion abnormality, or significant ST-segment-T wave (ST-T) changes in ECG)
- Untreated clinically significant CAD requiring revascularization
- Hemoglobin value below 8 mg/d, and/or creatinine kinase ≥3 times ULN, and/or AST or ALT ≥3 times ULN
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 |
|---|---|---|
| AspirinAlso: Acetyl Salicyl AcidOnce daily application of platelet inhibiting medication | Drug | Aspirin, Aspirin-Atorvastatin |
| AtorvastatinAlso: StatinOnce daily application of lipid lowering medication | Drug | Aspirin-Atorvastatin, Atorvastatin |
| Placebo AspirinAlso: Placebo Oral TabletOnce daily application of placebo | Drug | Atorvastatin, Placebo |
| Placebo AtorvastatinAlso: Placebo Oral TabletOnce daily application of placebo | Drug | Aspirin, Placebo |
Primary outcome
Myocardial infarction and/ or cardiovascular death and/ or revascularization
Time frame: Until last patient has completed 12 months of follow-up
Time to myocardial infarction, coronary revascularization, or death, whatever comes first
Results and safety
The study was stopped early (reason given: insufficient recruitment due to the pandemic situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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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.
Mahir Karakas, MD study chair
University Heart Center Hamburg
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin and Atorvastatin in people with Acute Chest Syndrome, run by Dr. med. Mahir Karakas at 7 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: insufficient recruitment due to the pandemic situation). Results are not available in the source record.
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?
Myocardial infarction and/ or cardiovascular death and/ or revascularization (time frame: Until last patient has completed 12 months of follow-up). 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 24 May 2022.