Not yet recruitingPHASE4INTERVENTIONAL

Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial

The SCAD-ALIGN trial is looking at better ways to treat Spontaneous Coronary Artery Dissection (SCAD), a specific type of heart attack. Unlike typical heart attacks, SCAD happens when a tear forms in a heart artery, often in younger women without common risk factors. This study compares two different anti-clotting medication approaches: a standard, more intensive treatment (two medicines) versus a milder treatment (one medicine). The goal is to see if the milder approach is better, as intensive treatment might sometimes slow healing in SCAD. The results will help doctors worldwide improve care for people with SCAD.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

3,518

Start

01 Mar 2027

Estimated completion

28 Feb 2033

SCAD ACS (Acute Coronary Syndrome)

What is this study about?

Imagine your heart has important pipes called coronary arteries that carry blood. Sometimes, one of these pipes can get a tear or a bruise inside its wall, causing blood to get trapped between the layers. This can block the pipe, leading to a heart attack. This specific type of heart attack is called Spontaneous Coronary Artery Dissection, or SCAD. It's different from the more common heart attacks where pipes get blocked by fatty build-up, and it often affects younger women who don't have the usual risk factors for heart disease.

After a SCAD heart attack, doctors often give medicines to prevent blood clots. These are called antiplatelet medicines. We know from other types of heart attacks that these medicines are very important. However, in SCAD, the problem isn't always a blood clot but rather the tear in the artery wall. Doctors wonder if giving very strong antiplatelet medicines might sometimes make the tear worse or slow down the healing process.

This study, called SCAD-ALIGN, wants to find out if a less intensive antiplatelet treatment might actually be better for people with SCAD. It compares two approaches: one uses a single anti-clotting medicine for three months, and the other uses two medicines for three months, followed by one medicine for another nine months. By comparing these, the study hopes to find the best way to help people recover from SCAD and improve their long-term health, contributing to clearer treatment guidelines for doctors everywhere.

Key takeaways

SCAD is a unique type of heart attack, often affecting younger women.
This study compares two anti-clotting treatment strategies for SCAD.
It aims to find out if a less intensive treatment is better for healing SCAD.
Participation involves taking medication and attending follow-up appointments.
The results will help doctors worldwide improve SCAD treatment guidelines.

Who may be eligible?

To join this study, you must be 18 years or older and have recently had a heart attack caused by SCAD. Your doctors must have decided that your SCAD can be managed without surgery or stents, meaning they plan for your artery to heal on its own.

You cannot join if you are allergic to the study medications, or if you are already taking other anti-clotting medicines for a different medical reason. You also can't participate if you have very severe heart problems, a history of major bleeding, or a condition that makes you bleed easily. Pregnant or breastfeeding women, and those in other drug trials, are also unable to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Have you recently had a heart attack caused by SCAD?
Has your doctor decided to manage your SCAD without surgery or stents?
Are you able to provide your consent to join the study?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you will be randomly assigned to one of two treatment groups, meaning you'll get either the less intensive or the more intensive anti-clotting medication. You will take these medications for up to 12 months. Over this year, you'll have regular follow-up appointments, which may involve health checks and questionnaires, to see how you're doing. The study team will explain all the visits and tests involved, and they will be there to support you throughout the entire 12-month period.

Potential risks and benefits

Taking part in this study could potentially help identify the most effective and safest anti-clotting treatment for SCAD, which could improve care for future patients, including yourself. However, as with any medication, there are potential side effects, especially with anti-clotting drugs which can increase the risk of bleeding. The study carefully monitors participants for any health changes or side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Division of Cardiology, Vancouver General Hospital, University of British Columbia
Verified postcode
Vancouver, Canada
University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany
Division of Cardiology, St. Antonius Hospital
Verified postcode
Nieuwegein, Netherlands
Department of Cardiology and Department of Medical and Health Sciences, Linköping University
Verified postcode
Linköping, Sweden
University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom

Common questions

What is SCAD?

SCAD stands for Spontaneous Coronary Artery Dissection. It's a less common type of heart attack where a tear occurs in the wall of a heart artery, often in younger women, without the usual causes like fatty blockages.

Why is this study needed?

Because SCAD is different from other heart attacks, doctors aren't sure if the usual strong anti-clotting treatments are best. This study aims to find out if a milder anti-clotting approach might be more beneficial for people with SCAD.

What kind of medication will I take?

You'll be given anti-clotting medications, specifically aspirin (acetylsalicylic acid) and/or clopidogrel, depending on which treatment group you are assigned to. These are common medicines used to prevent blood clots.

How long will the treatment last?

Depending on your assigned group, you will take one or two anti-clotting medications for three months, and then one medication for an additional nine months, making a total of 12 months of treatment.

What does 'conservatively managed' mean?

It means your doctors plan to treat your SCAD without surgery or inserting a stent to open the artery. Instead, they expect the artery to heal on its own with medication and careful monitoring.

How to find out more

Stefan Blankenberg, MD

s.blankenberg@uke.de +49 407410 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.