Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin (GRAY-ZONE)
-
- STATUS
- Recruiting
-
- End date
- Jun 8, 2023
-
- participants needed
- 3000
-
- sponsor
- Dr. med. Mahir Karakas
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
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).
Details
| Condition | Acute Chest Syndrome |
|---|---|
| Treatment | Atorvastatin, Aspirin, Placebo Aspirin, Placebo Atorvastatin |
| Clinical Study Identifier | NCT03820466 |
| Sponsor | Dr. med. Mahir Karakas |
| Last Modified on | 28 February 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer