NCT01586702: INSPiRE-TMS

Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car

Completed NA Last updated 22 July 2019

What this trial tests

NA trial testing Patient centered structured support program in Mini-Stroke in 2,082 participants. Completed in 1 May 2019.

Timeline

1 September 2011

Primary endpoint
1 December 2018

1 May 2019

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,082
Start date	1 September 2011
Primary completion	1 December 2018
Estimated completion	1 May 2019
Sites	1 location across Germany

Drugs / interventions tested

• Patient centered structured support program

Conditions studied

• Mini-Stroke — all drugs for Mini-Stroke →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Mini-Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death
  Time frame: Up to 6 years from inclusion
  Stroke: Acute (focal-) neurological syndrome, caused by brain infarction or intracerebral hemorrhage Major coronary event:Including instable Angina pectoris, STEMI and non-STEMI Vascular death: Caused by stroke (within 30 days of event), or major coronary event (within 7 days of event), or non-cerebral hemorrhage, or by peripheral arterial disease 30 days after vascular event or vascular intervent

Sponsor's own description

Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial.
   Ahmadi M, Laumeier I, Ihl T, Steinicke M, et al · · 2020 · cited 75× · PMID 31708447 · DOI 10.1016/s1474-4422(19)30369-2
2. Interventions for improving modifiable risk factor control in the secondary prevention of stroke.
   Bridgwood B, Lager KE, Mistri AK, Khunti K, et al · · 2018 · cited 66× · PMID 29734470 · DOI 10.1002/14651858.cd009103.pub3
3. Secondary prevention after minor stroke and TIA - usual care and development of a support program.
   Leistner S, Benik S, Laumeier I, Ziegler A, et al · · 2012 · cited 22× · PMID 23284630 · DOI 10.1371/journal.pone.0049985
4. Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial.
   Ihl T, Ahmadi M, Laumeier I, Steinicke M, et al · · 2022 · cited 6× · PMID 35703097 · DOI 10.1161/strokeaha.120.037503
5. Personalized medicine for pathological circadian dysfunctions.
   Skelton RL, Kornhauser JM, Tate BA. · · 2015 · cited 5× · PMID 26150790 · DOI 10.3389/fphar.2015.00125
6. Baseline Cerebral Small Vessel Disease Predicting Long-Term Cognitive Decline in Transient Ischemic Attack Patients.
   Roesen P, Temuulen U, Rios AS, Ganeshan R, et al · · 2026 · PMID 41885058 · DOI 10.1111/ene.70578
7. Neuroimaging Correlates of Post-Stroke Pain After Ischemic Stroke: Secondary Analysis of the INSPiRE-TMS Trial
   Stegemann A, Rios AS, Khalil A, Grittner U, et al · · 2025 · DOI 10.1101/2025.08.07.25333248
8. Cerebral Small Vessel Disease and Cognitive Decline Following Transient Ischemic Attack: A Longitudinal Study
   Roesen P, Temuulen U, Rios AS, Ganeshan R, et al · · 2025 · DOI 10.1101/2025.03.05.25323459